A Study to Assess the Safety, Tolerability, and Pharmacok... | NCT03859323 | Trialant
NCT03859323
Sponsor
Shire
Status
Completed
Last Update Posted
Feb 25, 2021Actual
Enrollment
104Actual
Phase
Phase 1
Conditions
Healthy Volunteers
Interventions
SHP681
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03859323
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
SHP681-101
Secondary IDs
Not provided
Brief Title
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (Glucagon-like Peptide-2 [GLP-2] Analog-Fc Fusion) in Healthy Adult Participants
Official Title
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Ascending, Subcutaneous, Single and Multiple Doses of SHP681 (GLP-2 Analog-Fc Fusion) in Healthy Adult Subjects
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Feb 2021
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 26, 2019Actual
Primary Completion Date
Jan 6, 2020Actual
Completion Date
Jan 6, 2020Actual
First Submitted Date
Feb 28, 2019
First Submission Date that Met QC Criteria
Feb 28, 2019
First Posted Date
Mar 1, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Dec 23, 2020
Results First Submitted that Met QC Criteria
Feb 8, 2021
Results First Posted Date
Feb 25, 2021Actual
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 8, 2021
Last Update Posted Date
Feb 25, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
ShireINDUSTRY
Collaborators
Not provided
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 the study is to assess the safety and tolerability of single and multiple ascending subcutaneous (SC) doses of SHP681 in healthy adult participants.
Detailed Description
The study consists of a single ascending dose (SAD) portion and a multiple ascending dose (MAD) portion.
The study duration for the SAD portion of the study consists of a screening period of up to 28 days and 1 treatment period of 29 days. SAD portion of the study contains 5 cohorts and dose escalation will proceed sequentially to assess the following single SC doses of SHP681 or SHP681 matched placebo: 0.2 milligram per kilogram (mg/kg), 0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 4 mg/kg.
The study duration of the MAD portion comprises of a screening period up to 28 days and a treatment period of 57 days for each cohort. MAD portion of the study contains 6 cohorts and dose escalation will proceed sequentially to assess the following SC doses of SHP681 or SHP681 matched placebo: 0.2 mg/kg, 0.5 mg/kg, 1 mg/kg, 2 mg/kg, and 4 mg/kg once weekly for 5 weeks till 5 cohorts and the 6th cohort will receive 4 mg/kg SHP681 or matched placebo every 2 weeks over a 6-week period (3 doses).
Conditions Module
Conditions
Healthy Volunteers
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
104Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Single Ascending Dose (SAD): 0.2 mg/kg
Experimental
Participants will receive single subcutaneous (SC) injection of 0.2 mg/kg SHP681 in the abdomen.
Drug: SHP681
Single Ascending Dose (SAD): 0.5 mg/kg
Experimental
Participants will receive single SC injection of 0.5 mg/kg SHP681 in the abdomen.
Drug: SHP681
Single Ascending Dose (SAD): 1 mg/kg
Experimental
Participants will receive single SC injection of 1 mg/kg SHP681 in the abdomen.
Drug: SHP681
Single Ascending Dose (SAD): 2 mg/kg
Experimental
Participants will receive single SC injection of 2 mg/kg SHP681 in the abdomen.
Drug: SHP681
Single Ascending Dose (SAD): 4 mg/kg
Experimental
Participants will receive single SC injection of 4 mg/kg SHP681 in the abdomen.
Drug: SHP681
Single Ascending Dose (SAD): Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
SHP681
Drug
Participants will receive SC injection of SHP681 in the abdomen.
Multiple Ascending Dose (MAD): 0.2 mg/kg
Multiple Ascending Dose (MAD): 0.5 mg/kg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Single Ascending Dose (SAD)
Adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
From start of study drug administration up to follow-up (Day 29 for SAD)
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Multiple Ascending Dose (MAD)
AE was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
From start of study drug administration up to follow-up (Day 57 for MAD)
Secondary Outcomes
Measure
Description
Time Frame
Maximum Observed Plasma Concentration (Cmax) of SHP681 During Single Ascending Dose (SAD)
Cmax of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Time of the Last Measurable Concentration (Tlast) of SHP681 During Single Ascending Dose (SAD)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Ability to voluntarily provide written, signed, and dated informed consent to participate in the study.
An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Age 18-50 inclusive at the time of consent. The date of signature of the informed consent is defined as the beginning of the screening period. This inclusion criterion will only be assessed at the first screening visit.
Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
Considered "healthy" by the investigator. Healthy status is defined by absence of evidence of any active or chronic disease or condition based on a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, and urinalysis.
Body mass index between 18.0 kilograms per square meter (kg/m^2) and 30.0 kg/m^2 inclusive with a body weight 50-100 kg (110-220 pounds [lbs]). This inclusion criterion will only be assessed at the first screening visit.
Exclusion Criteria:
History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease that could affect the action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any of the stated ingredients.
Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.
Known history of alcohol or other substance abuse within the last year.
Donation of blood or blood products (example [eg], plasma or platelets) within 60 days prior to receiving the first dose of investigational product.
Within 30 days prior to the first dose of investigational product:
Have used an investigational product (if elimination half-life is less than (<) 6 days, otherwise 5 half-lives).
Have been enrolled in a clinical study.
Have had any substantial changes in eating habits, as assessed by the investigator.
Use of dipeptidyl peptidase (DPP)-4 inhibitors within 30 days or 5 half-lives, whichever is greater, prior to administration of the investigational product.
Confirmed systolic blood pressure greater than (>) 139 millimeters of mercury (mmHg) or <89mmHg, and diastolic blood pressure > 89mmHg or <49 mmHg.
Twelve-lead ECG demonstrating corrected QT interval by Fredericia (QTcF) >450 millisecond (msec) at screening. If QTcF exceeds 450 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF values should be used to determine the participant's eligibility.
Positive screen for alcohol or illicit drugs at screening or Day -1.
Male participants who consume more than 21 units of alcohol per week or 3 units per day. Female participants who consume more than 14 units of alcohol per week or 2 units per day.
(1 alcohol unit equal to [=] 1 beer or 1 wine (5 ounce [oz] per 150 milliliter [mL]) or 1 liquor (1.5 oz/40 mL) or 0.75 oz alcohol).
Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody screen.
Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch). Ex-users must report that they have stopped using tobacco for at least 30 days prior to receiving the first dose of investigational product.
Routine consumption of more than 2 units of caffeine per day or participants who experience headaches associated with caffeine withdrawal. (1 caffeine unit is contained in the following items: one 6 oz (180 mL) cup of coffee, two 12 oz (360 mL) cans of cola, one 12 oz cup of tea, three 1 oz (85 g) chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine).
Prior screen failure (unless Sponsor approval is given), randomization, participation, or enrollment in this study or prior exposure to any GLP-2 analogs.
Unresected gastrointestinal (GI) polyp, known polyposis condition, or premalignant changes in the GI tract.
Any history of malignancy in the GI tract or treatment for any other malignancy in the previous 5 years.
Current use of any medication (including over-the-counter, herbal, or homeopathic preparations; with the exception of hormonal replacement therapy or hormonal contraceptives and occasional use of ibuprofen or acetaminophen and pre-approved medication for sedation or other medications required during or after the endoscopy). Current use is defined as use within 14 days of the first dose of investigational product.
Findings of subclinical hepatobiliary disease, such as gallstones, on abdominal ultrasound at screening as determined by the Investigator in consultation with the Medical Monitor.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
50 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Study Director
Shire
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
New Orleans Center for Clinical Research
Knoxville
Tennessee
37920
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame
Not provided
Access Criteria
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
This study consisted of 2 parts: Part A - single ascending dose (SAD) and Part B - multiple ascending dose (MAD). A total of 104 participants were randomized in 2 parts with 30 participants to SAD and 74 participants to MAD, out of which 95 participants completed the study.
Recruitment Details
This study was conducted at single site in United States of America from 25 March 2019 (first participant first visit) and 06 January 2020 (last participant last visit).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1: Single Ascending Dose (SAD): Placebo
Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.
FG001
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 19, 2019
Dec 23, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Placebo Comparator
Participants will receive single SC injection of placebo matched to SHP681 in the abdomen.
Other: Placebo
Multiple Ascending Dose (MAD): 0.2 mg/kg
Experimental
Participants will receive SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen.
Drug: SHP681
Multiple Ascending Dose (MAD): 0.5 mg/kg
Experimental
Participants will receive SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen.
Drug: SHP681
Multiple Ascending Dose (MAD): 1 mg/kg
Experimental
Participants will receive SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen.
Drug: SHP681
Multiple Ascending Dose (MAD): 2 mg/kg
Experimental
Participants will receive SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen.
Drug: SHP681
Multiple Ascending Dose (MAD): 4 mg/kg
Experimental
Participants will receive SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen.
Drug: SHP681
Multiple Ascending Dose (MAD): Placebo
Placebo Comparator
Participants will receive SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen.
Other: Placebo
Multiple Ascending Dose (MAD): 1 mg/kg
Multiple Ascending Dose (MAD): 2 mg/kg
Multiple Ascending Dose (MAD): 4 mg/kg
Single Ascending Dose (SAD): 0.2 mg/kg
Single Ascending Dose (SAD): 0.5 mg/kg
Single Ascending Dose (SAD): 1 mg/kg
Single Ascending Dose (SAD): 2 mg/kg
Single Ascending Dose (SAD): 4 mg/kg
Placebo
Other
Participants will receive SC injection of placebo matched to SHP681 in the abdomen.
Multiple Ascending Dose (MAD): Placebo
Single Ascending Dose (SAD): Placebo
Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Single Ascending Dose (SAD) at Day 29
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in SAD at Day 29 were reported.
Day 29
Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 36
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 36 were reported.
Day 36
Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 57
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 57 were reported.
Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as Dose Divided by AUC0-inf (CL/F) of SHP681 During Single Ascending Dose (SAD)
CL/F of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Apparent Volume of Distribution Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as CL/F Divided by Lambda z (Vz/F) of SHP681 During Single Ascending Dose (SAD)
Vz/F of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Average Concentration From Time Zero to 24 Hours Post First Dose (Cavg,0-24) of SHP681 Post First Dose During Multiple Ascending Dose (MAD)
Cavg,0-24 of SHP681 post first dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
3, 6, 12, 24 hours post-dose on Day 1
Observed Concentration at the End of Each Dosing Interval (Immediately Before Next Dose) (Ctrough) of SHP681 for the First 5 Cohorts and Immediately Before 2nd and 3rd Dose of the 6th MAD Cohort During Multiple Ascending Dose (MAD)
Ctrough of SHP681 for the First 5 cohorts and immediately before 2nd and 3rd dose of the 6th MAD cohort during MAD was reported.
Pre-dose on Days 8, 15, 22 and 29
Maximum Concentration During the Dosing Interval Occurring at Tmax (Cmax) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
Cmax of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Time of the Last Measurable Concentration (Tlast) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
Tlast of SHP681 post fifth dose during MAD was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
tmax of SHP681 post fifth dose during MAD was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Area Under the Curve for the Defined Interval Between Doses (Only Calculated if Interpretable) (AUC0-tau) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
AUC0-tau of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
AUC0-last of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Area Under the Curve Extrapolated to Infinity (AUC0-inf) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
AUC0-inf of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Average Concentration From Time Zero to 24 Hours Post Dose (Cavg,0-24) of SHP681 During Multiple Ascending Dose (MAD)
Cavg,0-24 of SHP681 during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Terminal Half-life (t1/2) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
t1/2 of SHP681 post fifth dose during MAD was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
First Order Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
Lambda z of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Apparent Total Body Clearance Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as Dose Divided by AUCtau (CL/F) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
CL/F of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Apparent Volume of Distribution Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as CL/F Divided by Lambda z (Vz/F) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
Vz/F of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
FG002
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
FG003
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
FG004
Part 1: Single Ascending Dose (SAD): 2 mg/kg
Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
FG005
Part 1: Single Ascending Dose (SAD): 4 mg/kg
Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.
FG006
Part 2: Multiple Ascending Dose (MAD): Placebo
Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
FG007
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
FG008
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
FG009
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
FG010
Part 2: Multiple Ascending Dose (MAD): 2 mg/kg
Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
FG011
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg
Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
FG012
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)
Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
FG0005 subjects
FG0015 subjects
FG0025 subjects
FG0035 subjects
FG0045 subjects
FG0055 subjects
FG00612 subjects
FG00710 subjects
FG00810 subjects
FG00910 subjects
FG01010 subjects
FG01112 subjects
FG01210 subjects
COMPLETED
FG0005 subjects
FG0015 subjects
FG0024 subjects
FG0035 subjects
FG0045 subjects
FG0054 subjects
FG00611 subjects
FG00710 subjects
FG00810 subjects
FG0098 subjects
FG0109 subjects
FG01110 subjects
FG0129 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0092 subjects
FG0101 subjects
FG0112 subjects
FG0121 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety Analysis Set (SAS) included participants who had received at least one dose of TAK-681 or placebo.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1: Single Ascending Dose (SAD): Placebo
Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.
BG001
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
BG002
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
BG003
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
BG004
Part 1: Single Ascending Dose (SAD): 2 mg/kg
Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
BG005
Part 1: Single Ascending Dose (SAD): 4 mg/kg
Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.
BG006
Part 2: Multiple Ascending Dose (MAD): Placebo
Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
BG007
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
BG008
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
BG009
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
BG010
Part 2: Multiple Ascending Dose (MAD): 2 mg/kg
Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
BG011
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg
Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
BG012
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)
Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0005
BG0015
BG0025
BG0035
BG0045
BG0055
BG00612
BG00710
BG00810
BG00910
BG01010
BG01112
BG01210
BG013104
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00033.6± 12.93
BG00128.8± 7.60
BG00238.0± 9.19
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
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), Serious TEAEs and TEAEs Based on Severity to SHP681 in Single Ascending Dose (SAD)
Adverse event (AE) was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
SAS included participants who had received at least 1 dose of SHP681 or placebo.
Posted
Count of Participants
Participants
From start of study drug administration up to follow-up (Day 29 for SAD)
ID
Title
Description
OG000
Part 1: Single Ascending Dose (SAD): Placebo
Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG003
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
OG004
Part 1: Single Ascending Dose (SAD): 2 mg/kg
Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
OG005
Part 1: Single Ascending Dose (SAD): 4 mg/kg
Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.
Units
Counts
Participants
OG0005
OG0015
OG0025
OG003
Title
Denominators
Categories
Participants with TEAEs
Title
Measurements
OG0003
OG0013
OG0022
OG003
Primary
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Based on Severity to SHP681 in Multiple Ascending Dose (MAD)
AE was any unfavorable and unintended sign, symptom, or disease temporally associated with study or use of investigational drug product (IP), whether or not the AE was considered related to IP. TEAEs: AEs occurring or worsening at or after first dose of IP or ongoing at time of enrollment. SAE :untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent, significant disability/incapacity, a congenital abnormality/birth defect, an important medical event. Severity: Mild: event that does not generally interfere with usual activities of daily living; Moderate: event that interferes with usual activities of daily living, causing discomfort, permanent risk of harm; Severe: AE that interrupts usual activities of daily living, significantly affects clinical status, or may require intensive therapeutic intervention.
SAS included participants who had received at least 1 dose of SHP681 or placebo.
Posted
Count of Participants
Participants
From start of study drug administration up to follow-up (Day 57 for MAD)
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): Placebo
Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Primary
Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Single Ascending Dose (SAD) at Day 29
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in SAD at Day 29 were reported.
SAS included participants who had received at least 1 dose of SHP681 or placebo. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Day 29
ID
Title
Description
OG000
Part 1: Single Ascending Dose (SAD): Placebo
Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG003
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Primary
Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 36
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 36 were reported.
SAS included participants who had received at least 1 dose of SHP681 or placebo. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Day 36
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): Placebo
Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG003
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Primary
Number of Participants With Anti-drug Antibody (ADA) to SHP681 in Multiple Ascending Dose (MAD) at Day 57
Antibody testing was conducted using an electro chemiluminescent signal method. Number of participants with ADA to SHP681 in MAD at Day 57 were reported.
SAS included participants who had received at least 1 dose of SHP681 or placebo. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure.
Posted
Count of Participants
Participants
Day 57
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): Placebo
Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG003
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Secondary
Maximum Observed Plasma Concentration (Cmax) of SHP681 During Single Ascending Dose (SAD)
Cmax of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
Pharmacokinetic (PK) analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
OG003
Secondary
Time of the Last Measurable Concentration (Tlast) of SHP681 During Single Ascending Dose (SAD)
tlast of SHP681 during SAD was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
OG003
Part 1: Single Ascending Dose (SAD): 2 mg/kg
Secondary
Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of SHP681 During Single Ascending Dose (SAD)
tmax of SHP681 during SAD was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
OG003
Part 1: Single Ascending Dose (SAD): 2 mg/kg
Secondary
Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of SHP681 During Single Ascending Dose (SAD)
AUC0-last of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
Secondary
Area Under the Curve Extrapolated to Infinity (AUC0-inf) of SHP681 During Single Ascending Dose (SAD)
AUC0-inf of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
OG003
Part 1: Single Ascending Dose (SAD): 2 mg/kg
Secondary
Terminal Half-life (t1/2) of SHP681 During Single Ascending Dose (SAD)
t1/2 of SHP681 during SAD was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
OG003
Part 1: Single Ascending Dose (SAD): 2 mg/kg
Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
Secondary
Average Concentration From Time Zero to 24 Hours Post Dose (Cavg,0-24) of SHP681 During Single Ascending Dose (SAD)
Cavg,0-24 of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Posted
Geometric Mean
Geometric Coefficient of Variation
Microgram per milliliter (mcg/mL)
Pre-dose, 3, 6, 12, 24 hours post-dose
ID
Title
Description
OG000
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
OG003
Part 1: Single Ascending Dose (SAD): 2 mg/kg
Secondary
First Order Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of SHP681 During Single Ascending Dose (SAD)
Lambda z of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
OG003
Secondary
Apparent Total Body Clearance for Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as Dose Divided by AUC0-inf (CL/F) of SHP681 During Single Ascending Dose (SAD)
CL/F of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
Secondary
Apparent Volume of Distribution Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as CL/F Divided by Lambda z (Vz/F) of SHP681 During Single Ascending Dose (SAD)
Vz/F of SHP681 during SAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
OG001
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
OG002
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
Secondary
Average Concentration From Time Zero to 24 Hours Post First Dose (Cavg,0-24) of SHP681 Post First Dose During Multiple Ascending Dose (MAD)
Cavg,0-24 of SHP681 post first dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg/mL
3, 6, 12, 24 hours post-dose on Day 1
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG003
Secondary
Observed Concentration at the End of Each Dosing Interval (Immediately Before Next Dose) (Ctrough) of SHP681 for the First 5 Cohorts and Immediately Before 2nd and 3rd Dose of the 6th MAD Cohort During Multiple Ascending Dose (MAD)
Ctrough of SHP681 for the First 5 cohorts and immediately before 2nd and 3rd dose of the 6th MAD cohort during MAD was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure at the specific categories.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg/mL
Pre-dose on Days 8, 15, 22 and 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
Secondary
Maximum Concentration During the Dosing Interval Occurring at Tmax (Cmax) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
Cmax of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg/mL
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
Secondary
Time of the Last Measurable Concentration (Tlast) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
Tlast of SHP681 post fifth dose during MAD was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Median
Full Range
Hour
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
Secondary
Time of Maximum Observed Concentration Sampled During a Dosing Interval (Tmax) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
tmax of SHP681 post fifth dose during MAD was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Median
Full Range
Hour
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
Secondary
Area Under the Curve for the Defined Interval Between Doses (Only Calculated if Interpretable) (AUC0-tau) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
AUC0-tau of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
Secondary
Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUC0-last) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
AUC0-last of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
Secondary
Area Under the Curve Extrapolated to Infinity (AUC0-inf) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
AUC0-inf of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*mcg/mL
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
Secondary
Average Concentration From Time Zero to 24 Hours Post Dose (Cavg,0-24) of SHP681 During Multiple Ascending Dose (MAD)
Cavg,0-24 of SHP681 during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg/mL
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
Secondary
Terminal Half-life (t1/2) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
t1/2 of SHP681 post fifth dose during MAD was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Median
Full Range
Hour
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG003
Secondary
First Order Rate Constant Associated With the Terminal (Log-linear) Portion of the Curve (Lambda z) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
Lambda z of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
1/h
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
Secondary
Apparent Total Body Clearance Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as Dose Divided by AUCtau (CL/F) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
CL/F of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Secondary
Apparent Volume of Distribution Following Extravascular Administration Divided by the Fraction of Dose Absorbed Calculated as CL/F Divided by Lambda z (Vz/F) of SHP681 Post Fifth Dose During Multiple Ascending Dose (MAD)
Vz/F of SHP681 post fifth dose during MAD was reported. Geometric mean and geometric coefficient of variation percent (CV%) was reported.
PK analysis set consisted of participants who received at least 1 dose of SHP681 and had at least 1 evaluable post-dose PK concentration value which was evaluable and interpretable. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liter
3, 6, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672 and up to 768 hours post--dose on Day 29
ID
Title
Description
OG000
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG001
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
OG002
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Time Frame
From start of study drug administration up to follow-up (Day 29 for SAD / Day 57 for MAD)
Description
Not provided
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
Part 1: Single Ascending Dose (SAD): Placebo
Participants received single subcutaneous (SC) injection of placebo matched to SHP681 in the abdomen on Day 1.
0
5
0
5
3
5
EG001
Part 1: Single Ascending Dose (SAD): 0.2 mg/kg
Participants received single SC injection of 0.2 milligrams per kilogram (mg/kg) SHP681 in the abdomen on Day 1.
0
5
0
5
3
5
EG002
Part 1: Single Ascending Dose (SAD): 0.5 mg/kg
Participants received single SC injection of 0.5 mg/kg SHP681 in the abdomen on Day 1.
0
5
0
5
2
5
EG003
Part 1: Single Ascending Dose (SAD): 1 mg/kg
Participants received single SC injection of 1 mg/kg SHP681 in the abdomen on Day 1.
0
5
0
5
4
5
EG004
Part 1: Single Ascending Dose (SAD): 2 mg/kg
Participants received single SC injection of 2 mg/kg SHP681 in the abdomen on Day 1.
0
5
0
5
3
5
EG005
Part 1: Single Ascending Dose (SAD): 4 mg/kg
Participants received single SC injection of 4 mg/kg SHP681 in the abdomen on Day 1.
0
5
0
5
2
5
EG006
Part 2: Multiple Ascending Dose (MAD): Placebo
Participants received SC injection of placebo matched to SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
0
12
0
12
9
12
EG007
Part 2: Multiple Ascending Dose (MAD): 0.2 mg/kg
Participants received SC injection of 0.2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
0
10
0
10
8
10
EG008
Part 2: Multiple Ascending Dose (MAD): 0.5 mg/kg
Participants received SC injection of 0.5 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
0
10
0
10
3
10
EG009
Part 2: Multiple Ascending Dose (MAD): 1 mg/kg
Participants received SC injection of 1 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
0
10
0
10
6
10
EG010
Part 2: Multiple Ascending Dose (MAD): 2 mg/kg
Participants received SC injection of 2 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
0
10
1
10
5
10
EG011
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg
Participants received SC injection of 4 mg/kg SHP681 once weekly for 5 weeks in the abdomen up to Day 29.
0
12
0
12
9
12
EG012
Part 2: Multiple Ascending Dose (MAD): 4 mg/kg (Q2W)
Participants received SC injection of placebo matched to SHP681 twice weekly (Q2W) for 5 weeks in the abdomen up to Day 29.
0
10
0
10
8
10
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cholecystitis
Hepatobiliary disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected10 at risk
EG0090 events0 affected10 at risk
EG0101 events1 affected10 at risk
EG0110 events0 affected12 at risk
EG0120 events0 affected10 at risk
Hepatocellular injury
Hepatobiliary disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG0030 events0 affected5 at risk
EG0040 events0 affected5 at risk
EG0050 events0 affected5 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected10 at risk
EG0080 events0 affected10 at risk
EG0091 events1 affected10 at risk
EG0100 events0 affected10 at risk
EG0110 events0 affected12 at risk
EG0120 events0 affected10 at risk
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Faeces hard
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal motility disorder
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Gastrointestinal sounds abnormal
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Hiatus hernia
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Proctalgia
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Application site irritation
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Injection site bruising
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Procedural dizziness
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Procedural nausea
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Amylase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0004 events3 affected5 at risk
EG0012 events2 affected5 at risk
EG0021 events1 affected5 at risk
EG003
Lipase increased
Investigations
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Polydipsia
Metabolism and nutrition disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Non-systematic Assessment
EG0001 events1 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Paranasal sinus discomfort
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Respiratory tract congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Macule
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0010 events0 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 22.0
Non-systematic Assessment
EG0000 events0 affected5 at risk
EG0012 events1 affected5 at risk
EG0020 events0 affected5 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.