Study of CD388 Intramuscular or Subcutaneous Administrati... | NCT05285137 | Trialant
NCT05285137
Sponsor
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Status
Completed
Last Update Posted
Feb 27, 2025Actual
Enrollment
77Actual
Phase
Phase 1
Conditions
Healthy
Interventions
CD388 Injection
Saline placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT05285137
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CD388.IM.SQ.1.01
Secondary IDs
Not provided
Brief Title
Study of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
Official Title
A Phase 1, Randomized, Double-Blind, Single-Dose and Repeat Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of CD388 Intramuscular or Subcutaneous Administration in Healthy Subjects
Acronym
Not provided
Organization
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)INDUSTRY
Status Module
Record Verification Date
Feb 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 14, 2022Actual
Primary Completion Date
Oct 27, 2023Actual
Completion Date
Oct 27, 2023Actual
First Submitted Date
Mar 8, 2022
First Submission Date that Met QC Criteria
Mar 15, 2022
First Posted Date
Mar 17, 2022Actual
Results Waived
Not provided
Results First Submitted Date
Dec 2, 2024
Results First Submitted that Met QC Criteria
Dec 2, 2024
Results First Posted Date
Jan 24, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 12, 2025
Last Update Posted Date
Feb 27, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)INDUSTRY
Collaborators
Name
Class
Janssen Pharmaceuticals
INDUSTRY
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this first-in-human study is to determine the safety and tolerability profile of CD388 Injection, as compared to saline placebo, when administered as a single dose to healthy adult subjects by injection either in the muscle or under the skin.
Detailed Description
A Phase 1, single-center, prospective, randomized, double-blind, single-dose and repeat single-dose, dose-escalation study to determine the safety, tolerability, and pharmacokinetics of CD388 Injection, as compared to saline placebo, when dosed either by intramuscular (IM) or subcutaneous (SQ) administration to healthy adult subjects.
Conditions Module
Conditions
Healthy
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
77Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1A (sentinel)
Experimental
Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 1A (main)
Experimental
Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by IM injection
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 1B (sentinel)
Experimental
Low dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 1B (main)
Experimental
Low dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 50 mg CD388 or placebo, administered by SQ injection
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 2A (sentinel)
Experimental
Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CD388 Injection
Combination Product
CD388 liquid for injection
Cohort 1A (main)
Cohort 1A (sentinel)
Cohort 1B (main)
Cohort 1B (sentinel)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Number of participants with at least one TEAE, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)
Severity of TEAEs After a Single Dose of CD388
Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)
Secondary Outcomes
Measure
Description
Time Frame
Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Willing and able to provide written informed consent.
Males and females 18 to 65 years of age, inclusive.
A female subject must meet one of the following criteria:
If of childbearing potential - agrees to use a highly effective, preferably user-independent method of contraception (failure rate of <1 percent per year when used consistently and correctly) for at least 30 days prior to screening and agrees to remain on a highly effective method until 205 days after last dose of study medication. Examples of highly-effective methods of contraception include: abstinence from heterosexual intercourse; hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch); intrauterine device (with or without hormones); or a double barrier method (e.g., condom and spermicide).
If a female of non-childbearing potential - should be surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by follicle-stimulating hormone (FSH) levels (≥40 milli-International units [mIU]/milliliter [mL]).
A woman of childbearing potential must have a negative highly sensitive serum pregnancy test (β-human chorionic gonadotropin) at screening and a negative urine pregnancy test on Day -1 before the first dose of study drug.
A male subject that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g., condom and spermicide) and agree to not donate sperm during the study and until at least 205 days after the last dose of the study medication.
Good health and without signs or symptoms of current illness.
Normal clinical examination, including:
No physical examination findings that an Investigator determines would interfere with interpretation of study results.
Screening ECG without clinically significant abnormalities.
Creatinine clearance (CrCL) ≥80 mL/minute as calculated using the Cockcroft-Gault equation.
Negative urine screen for drugs of abuse and alcohol at screening and Day -1.
Body mass index (BMI; weight in kilograms [kg] divided by height in meters [m] squared) between 18.0 and 32.0 kg/m^2, inclusive.
Willing to refrain from strenuous physical activity that could cause muscle aches or injury, including contact sports, at any time from screening through 30 days after any dose of study drug.
Subject has adequate venous access for blood collection.
Exclusion Criteria:
History of any hypersensitivity or allergic reaction to zanamivir or other neuraminidase inhibitors (i.e., laninamivir, oseltamivir, peramivir), or to excipients of the CD388 Injection drug formulation; or history of drug-induced exfoliative skin disorders (e.g., Stevens-Johnson syndrome [SJS], erythema multiforme, or toxic epidermal necrolysis [TEN]).
History of any of the following:
Allergies, anaphylaxis, skin rashes (foods such as milk, eggs, medications, vaccines, polyethylene glycol [PEG], etc.).
Chronic immune-mediated disease, positive first-degree family history of autoimmune diseases.
Atopic dermatitis or psoriasis.
Bleeding disorder.
Psychiatric condition, seizures, hallucinations, anxiety, depression, or treatment for mental conditions.
Migraines.
Syncope, or vasovagal syndrome with injections or blood draws.
Cardiac arrhythmia.
Subjects with one or more of the following laboratory abnormalities at screening as defined by the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events v2.1 (DAIDS 2017):
Serum creatinine, Grade ≥1 (≥1.1 × upper limit of normal [ULN])
Pancreatic amylase or lipase, Grade ≥2 (≥1.5 × ULN)
Any other toxicity Grade ≥2, except for Grade 2 elevations of triglycerides, low density lipoprotein cholesterol, and/or total cholesterol.
Any other laboratory abnormality considered to be clinically significant by the Investigator.
Note: Retesting of abnormal laboratory values that may lead to exclusion will be allowed once without prior asking approval from the Sponsor. Retesting will take place during a scheduled or unscheduled visit during screening. Subjects with a normal value at retest may be included.
Alcohol or drug addiction in the past 2 years.
Experiencing symptoms of acute illness or chronic disease within 14 days prior to check-in to the clinical research unit (CRU).
At screening, a positive result for hepatitis B virus surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) antibody.
A positive result at screening or CRU check-in for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by polymerase chain reaction (PCR). Beginning with Protocol Amendment 2, antigen testing may be used if PCR is not available.
Unwilling to comply with local health policy effective at the time regarding coronavirus disease 2019 (COVID-19).*
Women who are pregnant or nursing.
Received any over-the-counter (OTC) medications or nutritional supplements within 7 days, or any prescription medications within 14 days or <5 half-lives prior to dosing.
Current nicotine user or has quit habitual nicotine use in the 30 days prior to screening.
Received any vaccines or immunoglobulins within 28 days prior to dosing (90 days in case of intravenous immunoglobulin [IVIg] or biologics, or 14 days for COVID-19 vaccine).**
Donated blood (within 56 days of screening) or plasma (within 7 days of screening) or experienced significant blood loss or significant blood draw when participating in non-interventional clinical trials within 60 days prior to dosing.
Received a blood transfusion within 28 days prior to dosing.
Received any biologics within 90 days prior to dosing. Previous participation in another study within 30 days or 5 half-lives of the study drug, whichever is longer, prior to screening; prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable.
The PI considers that the volunteer should not participate in the study.
(*) Full COVID-19 vaccination prior to participation is strongly recommended.
(**) In the event a subject chooses to receive one of the two 2-dose approved or emergency-use-authorized COVID 19 vaccines (Comirnaty® [Pfizer], Spikevax™ [Moderna]) in the interval between two CRU stays (Cohort 2A/2B or Cohort 3A/3B), flexibility in timing of the second CRU stay should be applied, to allow appropriate receipt of the second vaccine dosage or booster (based on the respective vaccine label) + 14 days, to minimize risk of confounding findings/observations.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Ozlem Equils, MD
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Study Director
Debra J Kelsh, MD
Altasciences Company Inc.
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Altasciences Clinical Kansas, Inc.
Overland Park
Kansas
66212
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
A total of 77 participants were enrolled in the study at a single center, 33 of whom were randomized to receive study drug via intramuscular (IM) administration and 44 of whom were randomized to receive study drug via subcutaneous (SQ) administration.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
CD388: CD388 liquid for injection
FG001
CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
FG002
CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
FG003
Pooled Placebo IM
Participants randomized to receive a single dose of saline placebo, administered by IM injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg IM and CD388 450 mg IM arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
FG004
CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
CD388: CD388 liquid for injection
FG005
CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
FG006
CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
FG007
CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
CD388: CD388 liquid for injection
FG008
Pooled Placebo SQ
Participants randomized to receive a single dose of saline placebo, administered by SQ injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg SQ and CD388 450 mg SQ arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG0008 subjects
FG0018 subjects
FG0028 subjects
FG0039 subjects
FG0048 subjects
FG0058 subjects
FG0068 subjects
FG0078 subjects
FG00812 subjects
COMPLETED
FG0008 subjects
FG0016 subjects
FG0025 subjects
FG0035 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0023 subjects
FG0034 subjects
FG004
Type
Comment
Reasons
Failure to Meet Continuation Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
The Safety Population included all randomized participants who received any amount of study drug (77 total; 33 [IM route], 44 [SQ route]).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
CD388: CD388 liquid for injection
BG001
CD388 150 mg IM
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Single Dose of CD388
Number of participants with at least one TEAE, including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
The Safety Population included all randomized participants who received any amount of study drug (77 total; 33 [IM route], 44 [SQ route]).
Posted
Count of Participants
Participants
Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)
ID
Title
Description
OG000
CD388 50 mg IM
Adverse Events Module
Frequency Threshold
0
Time Frame
Adverse events were collected for all participants from the time of signing the informed consent form through the final study visit (Day 120 for the 50 mg dose arm [Cohorts 1A/1B]; Day 412 for the 150 mg and 450 mg dose arms [Cohorts 2A/2B and 3A/3B]; and Day 206 for the 900 mg dose arm [Cohort 4B]).
Description
All-Cause Mortality, Serious Adverse Events, and Other (Not Including Serious) Adverse Events were assessed in the Safety Population, which included all randomized participants who received any amount of study drug (77 total; 33 [IM route], 44 [SQ route]).
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 2B (sentinel)
Experimental
Mid dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 2B (main)
Experimental
Mid dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 150 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 3A (sentinel)
Experimental
High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 3A (main)
Experimental
High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by IM injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 3B (sentinel)
Experimental
High dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 3B (main)
Experimental
High dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 450 mg CD388 or placebo, administered by SQ injection, followed by another single dose of the same treatment (CD388 or placebo) administered by the same route after washout of 5 effective half-lives after the first dose
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 4B (sentinel)
Experimental
Highest dose level: 2 subjects randomized at a ratio of 1:1 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 4B (main)
Experimental
Highest dose level: 9 subjects randomized at a ratio of 7:2 to receive a single dose of 900 mg CD388 or placebo, administered by SQ injection
Combination Product: CD388 Injection
Drug: Saline placebo
Cohort 2A (main)
Cohort 2A (sentinel)
Cohort 2B (main)
Cohort 2B (sentinel)
Cohort 3A (main)
Cohort 3A (sentinel)
Cohort 3B (main)
Cohort 3B (sentinel)
Cohort 4B (main)
Cohort 4B (sentinel)
Saline placebo
Drug
Sterile normal saline for injection
Cohort 1A (main)
Cohort 1A (sentinel)
Cohort 1B (main)
Cohort 1B (sentinel)
Cohort 2A (main)
Cohort 2A (sentinel)
Cohort 2B (main)
Cohort 2B (sentinel)
Cohort 3A (main)
Cohort 3A (sentinel)
Cohort 3B (main)
Cohort 3B (sentinel)
Cohort 4B (main)
Cohort 4B (sentinel)
Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Apparent Clearance (CL/F) Following a Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Apparent Clearance (CL/F) Following a Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following the first single dose of CD388 administered by either IM or SQ injection.
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388
Number of participants with at least one TEAE, including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.
Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)
Severity of TEAEs After a Repeated Single Dose of CD388
Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.
Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)
8 subjects
FG0058 subjects
FG0064 subjects
FG0078 subjects
FG00810 subjects
0 subjects
FG0050 subjects
FG0064 subjects
FG0070 subjects
FG0082 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
FG0070 subjects
FG0081 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0033 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
BG002
CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
BG003
Pooled Placebo IM
Participants randomized to receive a single dose of saline placebo, administered by IM injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg IM and CD388 450 mg IM arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
BG004
CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
CD388: CD388 liquid for injection
BG005
CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
BG006
CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
BG007
CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
CD388: CD388 liquid for injection
BG008
Pooled Placebo SQ
Participants randomized to receive a single dose of saline placebo, administered by SQ injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg SQ and CD388 450 mg SQ arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
BG009
Total
Total of all reporting groups
8
BG0018
BG0028
BG0039
BG0048
BG0058
BG0068
BG0078
BG00812
BG00977
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00038.9± 7.77
BG00141.1± 12.83
BG00238.6± 12.73
BG00339.0± 15.51
BG00442.8± 12.58
BG00532.8± 10.75
BG00639.3± 14.95
BG00741.9± 13.97
BG00839.4± 13.82
BG00939.3± 12.62
Age, Continuous
Median
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00037.0(30 to 55)
BG00138.5(24 to 57)
BG00232.5(28 to 63)
BG00330.0(23 to 65)
BG00445.5(21 to 56)
BG00530.5(22 to 50)
BG00635.5(19 to 62)
BG00734.0(29 to 65)
BG00837.5(18 to 59)
BG00935.0(18 to 65)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG0014
BG0021
BG0035
BG0043
BG0051
BG0062
BG0071
BG0085
BG00923
Male
BG0007
BG0014
BG0027
BG0034
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0013
BG0021
BG0030
BG0040
BG0051
BG0061
BG0070
BG0080
BG0096
Not Hispanic or Latino
BG0008
BG0015
BG0027
BG0039
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Asian
BG0000
BG0010
BG0021
BG0031
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0003
BG0013
BG0023
BG0034
BG004
White
BG0005
BG0014
BG0024
BG0033
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0011
BG0020
BG0031
BG004
Weight
Mean
Standard Deviation
kilograms (kg)
Title
Denominators
Categories
Title
Measurements
BG00086.19± 5.680
BG00179.53± 11.945
BG00279.51± 16.157
BG00379.97± 12.596
BG00483.15± 19.835
BG00581.03± 17.053
BG00685.28± 16.085
BG00786.30± 10.079
BG00876.73± 13.775
BG00981.67± 13.847
Weight
Median
Full Range
kg
Title
Denominators
Categories
Title
Measurements
BG00085.50(77.6 to 95.3)
BG00180.40(64.8 to 99.9)
BG00275.60(63.0 to 105.9)
BG00380.90(55.0 to 95.2)
BG00478.75(59.9 to 112.5)
BG00578.20(59.5 to 115.8)
BG00683.75(64.1 to 118.6)
BG00787.90(68.5 to 99.9)
BG00879.50(55.4 to 101.7)
BG00981.70(55.0 to 118.6)
Height
Mean
Standard Deviation
centimeters
Title
Denominators
Categories
Title
Measurements
BG000178.88± 8.919
BG001172.25± 11.498
BG002174.50± 6.655
BG003172.00± 10.283
BG004173.38± 11.975
BG005172.38± 10.993
BG006172.00± 11.514
BG007176.19± 7.348
BG008171.17± 7.884
BG009173.49± 9.529
Height
Median
Full Range
centimeters
Title
Denominators
Categories
Title
Measurements
BG000179.00(168.0 to 193.0)
BG001173.50(154.0 to 185.0)
BG002176.00(164.0 to 184.0)
BG003177.00(153.0 to 184.0)
BG004176.50(157.0 to 190.0)
BG005174.00(155.0 to 191.0)
BG006169.50(159.0 to 193.0)
BG007176.75(165.0 to 187.0)
BG008171.50(159.0 to 186.0)
BG009175.00(153.0 to 193.0)
Body Mass Index
Mean
Standard Deviation
kilograms/meter^2 (kg/m^2)
Title
Denominators
Categories
Title
Measurements
BG00027.10± 3.033
BG00126.78± 2.690
BG00225.90± 3.502
BG00327.02± 3.609
BG00427.29± 3.311
BG00527.11± 3.740
BG00628.64± 2.978
BG00727.78± 2.606
BG00826.05± 3.345
BG00927.02± 3.163
Body Mass Index
Median
Full Range
kg/m^2
Title
Denominators
Categories
Title
Measurements
BG00027.95(22.2 to 30.9)
BG00126.95(22.4 to 29.8)
BG00225.20(21.6 to 31.3)
BG00328.70(20.0 to 30.8)
BG00427.30(23.3 to 31.2)
BG00527.00(19.7 to 31.7)
BG00629.35(23.8 to 31.8)
BG00726.80(24.6 to 31.7)
BG00826.05(21.1 to 30.5)
BG00927.00(19.7 to 31.8)
Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
CD388: CD388 liquid for injection
OG001
CD388 150 mg IM
Participants randomized to Cohort 2A to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG002
CD388 450 mg IM
Participants randomized to Cohort 3A to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG003
Pooled Placebo IM
Participants randomized to Cohort 1A, 2A, or 3A to receive a single dose of saline placebo, administered by IM injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg IM (Cohort 2A) and CD388 450 mg IM (Cohort 3A) arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
OG004
CD388 50 mg SQ
Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
CD388: CD388 liquid for injection
OG005
CD388 150 mg SQ
Participants randomized to Cohort 2B to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG006
CD388 450 mg SQ
Participants randomized to Cohort 3B to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG007
CD388 900 mg SQ
Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection.
CD388: CD388 liquid for injection
OG008
Pooled Placebo SQ
Participants randomized to Cohort 1B, 2B, 3B, or 4B to receive a single dose of saline placebo, administered by SQ injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg SQ (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
Units
Counts
Participants
OG0008
OG0018
OG0028
OG0039
OG0048
OG0058
OG0068
OG0078
OG00812
Title
Denominators
Categories
Participants with at least one TEAE
Title
Measurements
OG0005
OG0015
OG0025
OG0038
OG0045
OG0054
OG0065
OG0073
OG0087
Participants with AEs leading to study withdrawal
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Severity of TEAEs After a Single Dose of CD388
Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to adverse events (AEs) and serious adverse events (SAEs) (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, electrocardiogram (ECG), and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a single dose of CD388.
The Safety Population included all randomized participants who received any amount of study drug (77 total; 33 [IM route], 44 [SQ route]).
Posted
Count of Participants
Participants
Day 1 through Day 120 (±14 days; Cohorts 1A/1B only); Day 1 through Day 374 (±14 days; Cohorts 2A/2B and 3A/3B); or Day 1 through Day 206 (±10 days; Cohort 4B only)
ID
Title
Description
OG000
CD388 50 mg IM
Participants randomized to Cohort 1A to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
CD388: CD388 liquid for injection
OG001
CD388 150 mg IM
Participants randomized to Cohort 2A to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG002
CD388 450 mg IM
Participants randomized to Cohort 3A to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG003
Pooled Placebo IM
Participants randomized to Cohort 1A, 2A, or 3A to receive a single dose of saline placebo, administered by IM injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg IM (Cohort 2A) and CD388 450 mg IM (Cohort 3A) arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
OG004
CD388 50 mg SQ
Participants randomized to Cohort 1B to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
CD388: CD388 liquid for injection
OG005
CD388 150 mg SQ
Participants randomized to Cohort 2B to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG006
CD388 450 mg SQ
Participants randomized to Cohort 3B to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG007
CD388 900 mg SQ
Participants randomized to Cohort 4B to receive a single dose of 900 mg CD388, administered by SQ injection.
CD388: CD388 liquid for injection
OG008
Pooled Placebo SQ
Participants randomized to Cohort 1B, 2B, 3B, or 4B to receive a single dose of saline placebo, administered by SQ injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg SQ (Cohort 2B) and CD388 450 mg SQ (Cohort 3B) arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Mild
Title
Measurements
OG0005
OG0015
OG0022
OG003
Secondary
Mean Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.
The Pharmacokinetic (PK) Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Mean
Standard Deviation
micrograms/milliliter (ug/mL)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0004.13± 0.747
OG00110.4± 2.44
OG00248.6± 11.7
OG003
Secondary
Median Peak Plasma Concentration (Cmax) Following a Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Median
Full Range
micrograms/milliliter (ug/mL)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0003.96(2.91 to 5.34)
OG00110.4(6.52 to 13.6)
OG00248.0(35.2 to 67.7)
OG003
Secondary
Mean Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Mean
Standard Deviation
hours (h)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG000111.08± 72.42
OG001159.03± 83.10
OG00285.64± 42.19
OG003
Secondary
Median Time to Maximum Plasma Concentration (Tmax) Following a Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Median
Full Range
hours (h)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00096.07(48.17 to 240.00)
OG001131.98(71.97 to 312.00)
OG00278.31(24.17 to 144.00)
OG003
Secondary
Mean Terminal Elimination Half-life (t½) Following a Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Mean
Standard Deviation
hours (h)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001234.41± 140.04
OG0011192.03± 235.80
OG0021006.20± 314.39
OG003
Secondary
MedianTerminal Elimination Half-life (t½) Following a Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Median
Full Range
hours (h)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001275.62(985.09 to 1390.45)
OG0011285.85(783.24 to 1471.71)
OG0021137.42(540.88 to 1384.09)
Secondary
Mean Apparent Clearance (CL/F) Following a Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Mean
Standard Deviation
liters/hour (L/h)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.00751± 0.00119
OG0010.00867± 0.00177
OG0020.00766± 0.00199
OG003
Secondary
Median Apparent Clearance (CL/F) Following a Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Median
Full Range
liters/hour (L/h)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.00707(0.00614 to 0.00991)
OG0010.00851(0.00640 to 0.0112)
OG0020.00726(0.00571 to 0.0116)
Secondary
Mean Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Mean
Standard Deviation
liters (L)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00013.3± 1.91
OG00114.8± 4.40
OG00210.7± 2.99
OG003
Secondary
Median Apparent Volume of Distribution (V[z]/F) Following a Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Median
Full Range
liters (L)
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00013.9(10.3 to 15.8)
OG00114.4(11.1 to 23.9)
OG00210.9(6.47 to 15.1)
OG003
Secondary
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Mean
Standard Deviation
ug*h/mL
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0005450± 728
OG00115000± 4320
OG00253800± 12000
OG003
Secondary
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Median
Full Range
ug*h/mL
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0005460(4410 to 6530)
OG00115100(7250 to 21100)
OG00252100(37600 to 71200)
OG003
Secondary
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Mean
Standard Deviation
ug*h/mL
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0006790± 973
OG00117900± 3670
OG00261800± 13600
OG003
Secondary
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following the first single dose of CD388 administered by either IM or SQ injection.
The PK Population included all randomized participants who received at least a portion of 1 dose of CD388 and had at least 1 evaluable post-dose concentration value. Participants administered matching placebo were not included in the PK Population.
Posted
Median
Full Range
ug*h/mL
Days 1 through 7, 9, 11, 14, 21, and 30 (all cohorts) and at outpatient visits: Days 45, 60, 90, and 120 (Cohorts 1A/1B only); Days 45, 84, 126, and 168 (Cohorts 2A/2B and 3A/3B); or Days 45, 84, 126, 168, and 206 (Cohort 4B only)
ID
Title
Description
OG000
Cohort 1A CD388 50 mg IM
Participants randomized to receive a single dose of 50 milligrams (mg) CD388, administered by intramuscular (IM) injection.
OG001
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 1B CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
OG004
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG005
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG006
Cohort 4B CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
Units
Counts
Participants
OG0008
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0007080(5050 to 8140)
OG00117600(13300 to 23400)
OG00262100(38800 to 78800)
OG003
Secondary
Mean Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Mean
Standard Deviation
micrograms/milliliter (ug/mL)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00010.5± 3.30
OG00128.8± 7.66
OG00213.0± 5.34
OG003
Secondary
Median Peak Plasma Concentration (Cmax) Following a Repeated Single Administration of CD388
Evaluation of the maximum plasma concentration (Cmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Median
Full Range
micrograms/milliliter (ug/mL)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0009.94(6.68 to 14.4)
OG00129.8(18.0 to 38.3)
OG00212.5(6.84 to 22.0)
OG003
Secondary
Mean Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Mean
Standard Deviation
hours (h)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG000104.02± 81.25
OG001161.14± 75.53
OG002251.99± 200.79
OG003
Secondary
Median Time to Maximum Plasma Concentration (Tmax) Following a Repeated Single Administration of CD388
Evaluation of the time to maximum plasma concentration (Tmax) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Median
Full Range
hours (h)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00084.00(48.00 to 264.00)
OG001144.00(48.00 to 264.00)
OG002227.99(48.00 to 695.97)
OG003
Secondary
Mean Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Mean
Standard Deviation
hours (h)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001324.07± 198.33
OG0011408.43± 336.72
OG0021059.55± 409.51
OG003
Secondary
Median Terminal Elimination Half-life (t½) Following a Repeated Single Administration of CD388
Evaluation of the terminal elimination half-life (t½) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Median
Full Range
hours (h)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0001342.81(1108.91 to 1639.43)
OG0011506.38(670.64 to 1721.28)
OG0021218.60(508.57 to 1539.09)
Secondary
Mean Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Mean
Standard Deviation
liters/hour (L/h)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.00923± 0.00123
OG0010.00886± 0.00170
OG0020.00802± 0.00218
OG003
Secondary
Median Apparent Clearance (CL/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent clearance (CL/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Median
Full Range
liters/hour (L/h)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG0000.00954(0.00706 to 0.0104)
OG0010.00918(0.00642 to 0.0105)
OG0020.00866(0.00507 to 0.0116)
Secondary
Mean Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Mean
Standard Deviation
liters (L)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00017.4± 1.85
OG00117.8± 5.45
OG00211.7± 4.70
OG003
Secondary
Median Apparent Volume of Distribution (V[z]/F) Following a Repeated Single Administration of CD388
Evaluation of the apparent volume of distribution (V[z]/F) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Median
Full Range
liters (L)
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00016.6(15.4 to 20.2)
OG00116.7(10.1 to 26.0)
OG0029.46(7.45 to 19.2)
OG003
Secondary
Mean Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Mean
Standard Deviation
ug*h/mL
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00014400± 2050
OG00141300± 15400
OG00218000± 5090
OG003
Secondary
Median Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Quantifiable Sample (AUC[0-t]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 to time of last quantifiable sample (AUC[0-t]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Median
Full Range
ug*h/mL
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00013600(12800 to 18000)
OG00141800(13400 to 60600)
OG00216000(12900 to 26600)
OG003
Secondary
Mean Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Mean
Standard Deviation
ug*h/mL
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00016500± 2530
OG00152600± 10800
OG00220000± 5830
OG003
Secondary
Median Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUC[0-∞]) Following a Repeated Single Administration of CD388
Evaluation of the area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC[0-∞]) following a repeated single dose of CD388 administered by either IM or SQ injection (after washout of 5 effective half-lives from the first dose).
The PK Completer Population included all randomized participants who received 2 single doses of CD388 and obtained adequate PK samples for PK parameter estimation. Participants administered matching placebo were not included in the Completer PK Population.
Posted
Median
Full Range
ug*h/mL
At inpatient visits on Days 206 (i.e., Dose 2 Day 1) through 212, 214, 216, 219, 226, and 236; and at outpatient visits: Days 251, 290, 332, and 374 (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
Cohort 2A CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG001
Cohort 3A CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG002
Cohort 2B CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
OG003
Cohort 3B CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Units
Counts
Participants
OG0006
OG0017
OG0028
OG003
Title
Denominators
Categories
Title
Measurements
OG00015700(14500 to 21200)
OG00149000(42900 to 70100)
OG00217300(12900 to 29600)
OG003
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After a Repeated Single Dose of CD388
Number of participants with at least one TEAE, including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.
The Safety Population included all randomized participants who received any amount of study drug (77 total; 33 [IM route], 44 [SQ route]).
Posted
Count of Participants
Participants
Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
CD388 150 mg IM
Participants randomized to Cohort 2A to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG001
CD388 450 mg IM
Participants randomized to Cohort 3A to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG002
Pooled Placebo IM
Participants randomized to Cohort 2A or 3A to receive a single dose of saline placebo, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
OG003
CD388 150 mg SQ
Participants randomized to Cohort 2B to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG004
CD388 450 mg SQ
Participants randomized to Cohort 3B to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG005
Pooled Placebo SQ
Participants randomized to Cohort 2B or 3B to receive a single dose of saline placebo, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
Units
Counts
Participants
OG0006
OG0017
OG0024
OG003
Title
Denominators
Categories
Participants with at least one TEAE
Title
Measurements
OG0002
OG0014
OG0022
OG003
Secondary
Severity of TEAEs After a Repeated Single Dose of CD388
Maximum severity of TEAEs reported (in participants with at least one TEAE), including but not limited to AEs and SAEs (including systemic reactogenicity/injection site reactions and hypersensitivity reactions), and AEs leading to study drug discontinuation and/or study withdrawal, based on vital signs, 12-lead ECG, and clinical laboratory test (including hematology, coagulation, serum chemistry, and urinalysis) abnormalities following a repeated single dose of CD388.
The Safety Population included all randomized participants who received any amount of study drug (77 total; 33 [IM route], 44 [SQ route]).
Posted
Count of Participants
Participants
Day 207 through Day 412 (±10 days) (Cohorts 2A/2B and 3A/3B only)
ID
Title
Description
OG000
CD388 150 mg IM
Participants randomized to Cohort 2A to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG001
CD388 450 mg IM
Participants randomized to Cohort 3A to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG002
Pooled Placebo IM
Participants randomized to Cohort 2A or 3A to receive a single dose of saline placebo, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
OG003
CD388 150 mg SQ
Participants randomized to Cohort 2B to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG004
CD388 450 mg SQ
Participants randomized to Cohort 3B to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
OG005
Pooled Placebo SQ
Participants randomized to Cohort 2B or 3B to receive a single dose of saline placebo, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
Units
Counts
Participants
OG0006
OG0017
OG0024
OG003
Title
Denominators
Categories
Mild
Title
Measurements
OG0002
OG0012
OG0022
OG003
0
8
0
8
5
8
EG001
CD388 150 mg IM
Participants randomized to receive a single dose of 150 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
0
8
0
8
5
8
EG002
CD388 450 mg IM
Participants randomized to receive a single dose of 450 mg CD388, administered by IM injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
0
8
0
8
6
8
EG003
Pooled Placebo IM
Participants randomized to receive a single dose of saline placebo, administered by IM injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg IM and CD388 450 mg IM arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection
0
9
0
9
8
9
EG004
CD388 50 mg SQ
Participants randomized to receive a single dose of 50 mg CD388, administered by subcutaneous (SQ) injection.
CD388: CD388 liquid for injection
0
8
0
8
5
8
EG005
CD388 150 mg SQ
Participants randomized to receive a single dose of 150 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
0
8
0
8
4
8
EG006
CD388 450 mg SQ
Participants randomized to receive a single dose of 450 mg CD388, administered by SQ injection, followed by another single dose of the same treatment administered by the same route after washout of 5 effective half-lives after the first dose.
CD388: CD388 liquid for injection
0
8
0
8
6
8
EG007
CD388 900 mg SQ
Participants randomized to receive a single dose of 900 mg CD388, administered by SQ injection.
CD388: CD388 liquid for injection
0
8
0
8
3
8
EG008
Pooled Placebo SQ
Participants randomized to receive a single dose of saline placebo, administered by SQ injection. Of these participants, those that advanced through the study in cohorts with participants in the CD388 150 mg SQ and CD388 450 mg SQ arms received another single dose of saline placebo administered by the same route after washout of 5 effective half-lives after the first dose.
Saline placebo: Sterile normal saline for injection