A Study to Evaluate the Safety, Tolerability and Pharmaco... | NCT03038113 | Trialant
NCT03038113
Sponsor
Hoffmann-La Roche
Status
Completed
Last Update Posted
Dec 24, 2020Actual
Enrollment
119Actual
Phase
Phase 1
Conditions
Chronic Hepatitis B
Interventions
RO7062931
Placebo
Immune Modulator
Countries
Australia
Hong Kong
New Zealand
Singapore
South Korea
Taiwan
Thailand
Protocol Section
Identification Module
NCT ID
NCT03038113
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BP39405
Secondary IDs
Not provided
Brief Title
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B
Official Title
A Randomized, Sponsor-Open, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneous Administration of RO7062931 With Single Ascending Doses in Healthy Volunteers and Multiple Doses and Modified Regimens in Virologically Suppressed Patients With Chronic Hepatitis B Virus Infection
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Nov 2020
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
Feb 6, 2017Actual
Primary Completion Date
Oct 18, 2019Actual
Completion Date
Oct 18, 2019Actual
First Submitted Date
Jan 30, 2017
First Submission Date that Met QC Criteria
Jan 30, 2017
First Posted Date
Jan 31, 2017Estimated
Results Waived
Not provided
Results First Submitted Date
Oct 14, 2020
Results First Submitted that Met QC Criteria
Nov 30, 2020
Results First Posted Date
Dec 24, 2020Actual
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
Nov 30, 2020
Last Update Posted Date
Dec 24, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
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
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931. Part 1 will include only healthy participants and Part 2 will include only participants with chronic hepatitis B (CHB). Part 1 is an adaptive, single-ascending dose study with an adaptive dose-escalating schedule to determine the best dose to be evaluated in participants with CHB. Part 2 is an adaptive, parallel multiple-dose study comprised of three sub-parts which will be used to further refine the dose and dosing regimen, and to evaluate the safety and efficacy of RO7062931 when administered with standard-of-care (SoC) therapy.
Detailed Description
Not provided
Conditions Module
Conditions
Chronic Hepatitis B
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
119Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part 1: Single-Ascending Dose (SAD)
Experimental
Healthy volunteers will be enrolled in up to 8 cohorts with doses starting from 0.1 mg/kg and escalating sequentially after review of safety and pharmacokinetic (PK) data.
Drug: RO7062931
Drug: Placebo
Part 2: Multiple Ascending Dose
Experimental
Participants with Chronic Hepatitis B will enrolled in Part 2. In Part 2a, participants will receive two monthly injections of either 3 doses equivalent to a multiple of the saturation dose or placebo in a 1:1:1:1 ratio. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts where they will be dosed weekly (QW) or bi-weekly (Q2W). Each of the cohorts in Part 2b will include participants receiving active drug or placebo in a 3:1 ratio. In Part 2c, NUC-suppressed CHB participants will receive either RO7062931+NUC for up to 24 weeks, or RO7062931+NUC+an immune modulator for up to 48 weeks, at a dose determined from Part 2a and 2b. Part 2c may also enroll treatment-naive immune-active CHB participants.
Drug: RO7062931
Drug: Placebo
Drug: Immune Modulator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RO7062931
Drug
Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts QW or Q2W. In Part 2c, participants will receive RO7062831 QW on top of another therapy for up to 24 or 48 weeks.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
AEs of Special Interest were defined as: i.) elevated ALT/AST in combination with elevated bilirubin/clinical jaundice, ii.) suspected transmission of infectious agent by the study drug, iii.) severe injection site reactions, iv.) ALT elevation ≥10x ULN, v.) creatinine elevation ≥1.5x ULN or ≥50% from baseline.
Up to day 113
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Screening, Days -1, 2, 8, 15, 29, 85
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Secondary Outcomes
Measure
Description
Time Frame
Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
Days 1-8
Cmax After Multiple Ascending Doses - Part 2
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
FOR HEALTHY VOLUNTEERS ONLY - PART 1 -
A Body Mass Index (BMI) between 18 to 30 kg/m2 inclusive and a body weight of at least 50 kg.
Women should be of non-childbearing potential. A woman is considered to be of childbearing potential if she is post-menarcheal but has not reached a post-menopausal state and has not undergone surgical sterilization (removal of ovaries and/or uterus).
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose, and agree to refrain from donating sperm.
Non-smoker (nor tobacco containing products) for at least 90 days prior to dosing on Day 1 and agree to remain as non-smoker during the study.
FOR CHB PARTICIPANTS ONLY - PARTS 2a and 2b:
A BMI between 18 to 32 kg/m2 inclusive.
Chronic hepatitis B (HBV) infection.
Positive test for HBsAg for more than 6 months prior to randomization and HBsAg titer ≥ 10^3 IU/mL at screening.
On entecavir, tenofovir, adefovir or telbivudine treatment for at least 6 months prior to randomization and will remain on stable treatment during the study.
HBV deoxyribonucleic acid (DNA) ≤ 90 IU/mL for at least the preceding 6 months.
Screening laboratory values (hematology, chemistry, urinalysis) obtained up to 56 days prior to first study treatment within normal ranges.
Liver biopsy, fibroscan® or equivalent test obtained within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis
Women should be of non-childbearing potential. A woman is considered to be of childbearing potential if she is post-menarcheal but has not reached a post-menopausal state and has not undergone surgical sterilization (removal of ovaries and/or uterus).
Men must agree to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures during treatment and up to 105 days after the last dose, and agree to refrain from donating sperm.
FOR CHB PARTICIPANTS ONLY - PART 2c
BMI between 18 to 32 kg/m2 inclusive
CHB infection (HBsAg-positive for at least 6 months)
For NUC-suppressed CHB participants: Must have been treated with a single NUC for at least 12 months, and have been on the same NUC therapy for at least 3 months prior to screening; HBV DNA <lower limit of quantification (LLOQ) at screening and in the 6 months prior to screening (at least one measurement must be >30 days prior to screening); alanine aminotransferase (ALT) </=2x upper limit of normal (ULN) for >6 months prior to screening and confirmed at screening; total bilirubin within normal range at screening, except for patients with Gilbert's syndrome
For treatment-naive and immune-active participants: HBV DNA at screening >/=2x10^4 IU/mL for HBeAg positive participants, or >/=2x10^3 IU/mL for HBeAg negative participants; elevated serum ALT>2 ULN to </=5, 2 values within 6 months, at least one of which is at screening and that are at least 14 days apart; total bilirubin within normal range except for participants with Gilbert's syndrome
Screening laboratory values (hematology, chemistry, urinalysis) obtained up to 28 days prior to first study treatment within normal ranges
Liver biopsy, fibroscan, or equivalent test obtained within the last 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis
Women should be of non-childbearing potential
Men must agree to remain abstinent or use contraception, and agree to refrain from donating sperm
Exclusion Criteria:
FOR HEALTHY VOLUNTEERS ONLY - PART 1:
History of drug or alcohol abuse or dependence in previous 6 months.
Positive urine drug and alcohol screen or positive cotinine test at screening or Day -1.
Positive result on hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV) 1 and 2.
Confirmed blood pressure or resting pulse rate outside of accepted ranges.
Participation in an investigational drug or device study within 90 days prior to screening.
Donation of blood over 500 mL within three months prior to screening.
Any major illness within the one month, or any febrile illness within two weeks preceding the screening visit.
Alcohol consumption of more than 2 standard drinks per day on average.
FOR CHB PARTICIPANTS ONLY - PARTS 2a and 2b:
History or other evidence of bleeding from esophageal varices.
Decompensated liver disease.
History of or suspicion of hepatocellular carcinoma or alpha fetoprotein (AFP) ≥ 13 ng/mL at Screening
History or other evidence of a medical condition associated with chronic liver disease other than HBV infection.
Documented history or other evidence of metabolic liver disease within one year of randomization or documented history of infection with hepatitis D virus.
Positive test for hepatitis A (IgM anti-HAV), hepatitis C, or HIV.
Organ transplantation.
Significant acute infection or any other clinically significant illness within 2 weeks of randomization.
Abnormal renal function.
Participation in an investigational drug or device study within 30 days prior to randomization.
Donation or loss of blood over 500 mL within 3 months prior to starting study medication.
Administration of any blood product within 3 months of randomization.
History or evidence of alcohol abuse (consumption of more than 2 standard drinks per day on average).
FOR CHB PARTICIPANTS ONLY - PART 2c
History or other evidence of bleeding from esophageal varices
Evidence of liver cirrhosis or decompensated liver disease
One or more of the following laboratory abnormalities at screening: Total serum bilirubin > ULN (except for participants with Gilbert's disease); international normalized ratio (INR) > 1.1 ULN; serum albumin < 3.5 g/dL; AFP >13 ng/mL; positive results for anti-mitochondrial antibodies (AMA > 1:80), anti-nuclear antibody (ANA > 1:80), anti-smooth muscle antibody (ASMA > 1:40), anti-thyroperoxidase antibodies (a-TPO), anti-thyroglobulin, or anti-platelet antibodies; thyroid stimulating hormone (TSH) outside of normal range; platelet count <100,000 cells/mm^3; hemoglobin <12 g/dL (females) or <13 g/dL (males); white blood cell count <2500 cells/mm^3; and neutrophil count <1500 cells/mm^3
History or other evidence of a medical condition associated with chronic liver disease other than HBV infection
History of thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests
Documented history or other evidence of metabolic liver disease within one year of randomization
Positive test for hepatitis A, hepatitis C, or HIV
History of organ transplantation
Participation in an investigational drug or device study within 30 days prior to screening or previous treatment with an investigational agent for HBV within 6 months prior to screening
Significant acute infection or any other clinically significant illness within 2 weeks of randomization
Abnormal renal function, including serum creatinine > ULN or calculated creatinine clearance < 70 mL/min
Donation or loss of blood over 500 mL within 3 months prior to randomization
Administration of any blood product within 3 months prior to randomization
Gane E, Yuen MF, Kim DJ, Chan HL, Surujbally B, Pavlovic V, Das S, Triyatni M, Kazma R, Grippo JF, Buatois S, Lemenuel-Diot A, Krippendorff BF, Mueller H, Zhang Y, Kim HJ, Leerapun A, Lim TH, Lim YS, Tanwandee T, Kim W, Cheng W, Hu TH, Wat C. Clinical Study of Single-Stranded Oligonucleotide RO7062931 in Healthy Volunteers and Patients With Chronic Hepatitis B. Hepatology. 2021 Oct;74(4):1795-1808. doi: 10.1002/hep.31920. Epub 2021 Aug 25.
See Also Links
Not provided
Available IPD Information
Not provided
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
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
FG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
Mar 12, 2019
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
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Basic Science
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Part 1: Single-Ascending Dose (SAD)
Part 2: Multiple Ascending Dose
Placebo
Drug
Part 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts.
Part 1: Single-Ascending Dose (SAD)
Part 2: Multiple Ascending Dose
Immune Modulator
Drug
Participants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks.
Part 2: Multiple Ascending Dose
Screening, Days -1, 2, 8, 15, 29, at discontinuation, Days 36, 43, 57, 85, 113
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF > 500 msec, or > 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF > 500 msec, or > 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
Days 1-113
Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
Days 1-8
Tmax After Multiple Ascending Doses - Part 2
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
Days 1-113
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1
AUC0-inf was calculated based on non-compartmental analysis.
Days 1-8
AUC0-inf After Multiple Ascending Doses - Part 2
AUC0-inf was calculated based on non-compartmental analysis.
Days 1,22,29
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1
AUC0-last was calculated based on non-compartmental analysis.
Days 1-8
AUC0-last After Multiple Ascending Doses - Part 2
AUC0-last was calculated based on non-compartmental analysis.
Days 1,22,29
Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1
T1/2 was calculated based on non-compartmental analysis.
Days 1-8
Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2
T1/2 was calculated based on non-compartmental analysis.
Days 1-113
Total Clearance (CL) After Single Ascending Doses - Part 1
Apparent oral clearance was calculated from Dose/AUCinf.
Days 1-8
Total Clearance (CL) After Multiple Ascending Doses - Part 2
Apparent oral clearance was calculated from Dose/AUCinf.
Days 1-113
Volume of Distribution (Vss) After Single Ascending Doses - Part 1
Vss was calculated from dose/AUCinf
Days 1-8
Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2
Vss was calculated from dose/AUCinf
Days 1-113
Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Hours 0-4, 0-8, 0-12, and 0-24
Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Days 1-113
Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Days 1-113
Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Day 1 - Day 113
Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Day 1 - Day 113
Nedlands
Western Australia
6009
Australia
Queen Mary Hospital
Hong Kong
Hong Kong
Prince of Wales Hospital
Shatin, New Territories
Hong Kong
Auckland Clinical Studies
Auckland
1142
New Zealand
Middlemore Hospital
Auckland
1640
New Zealand
National University Hospital; Dept of Gastroenterology & Hepatology
Singapore
119228
Singapore
Singapore General Hospital; Gastroenterology & Hepatology
Singapore
169608
Singapore
Chuncheon Sacred Heart Hospital
Gangwon-Do
200-704
South Korea
Gangnam Severance Hospital
Seoul
06273
South Korea
ChungAng University Hospital
Seoul
06973
South Korea
University of Ulsan College of Medicine, Asan Medical Center, Digestive Disease Center
Seoul
138736
South Korea
SMG-SNU Boramae Medical Center
Seoul
156-707
South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
807
Taiwan
Chang Gung Medical Foundation - Kaohsiung Branch
Kaohsiung City
Taiwan
Taipei Veterans General Hospital
Taipei
112
Taiwan
Chang Gung Medical Foundation Linkou Branch
Taoyuan City
333
Taiwan
Siriraj Hospital; Dept. of Medicine
Bangkok
10700
Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
50200
Thailand
FG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
FG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
FG004
Part 1 - RO7062931 3.0 mg/kg
Participants received a single SC injection of 3.0 mg/kg RO7062931.
FG005
Part 1 - RO7062931 4.0 mg/kg
Participants received a single SC injection of 4.0 mg/kg RO7062931.
FG006
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
FG007
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
FG008
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
FG009
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
FG010
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
FG011
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
FG012
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
FG013
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
FG0008 subjects
FG0018 subjects
FG0028 subjects
FG0038 subjects
FG0048 subjects
FG0058 subjects
FG00612 subjects
FG0076 subjects
FG0087 subjects
FG0096 subjects
FG01014 subjects
FG0117 subjects
FG0124 subjects
FG01315 subjects
COMPLETED
FG0008 subjects
FG0018 subjects
FG0027 subjects
FG0038 subjects
FG0048 subjects
FG0058 subjects
FG00611 subjects
FG0076 subjects
FG0087 subjects
FG0096 subjects
FG01014 subjects
FG0117 subjects
FG0124 subjects
FG01314 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0131 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
BG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
BG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
BG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
BG004
Part 1 - RO7062931 3.0 mg/kg
Participants received a single SC injection of 3.0 mg/kg RO7062931.
BG005
Part 1 - RO7062931 4.0 mg/kg
Participants received a single SC injection of 4.0 mg/kg RO7062931.
BG006
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
BG007
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
BG008
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
BG009
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
BG010
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
BG011
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
BG012
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
BG013
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0008
BG0018
BG0028
BG0038
BG0048
BG0058
BG00612
BG0076
BG0087
BG0096
BG01014
BG0117
BG0124
BG01315
BG014119
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00029.8± 11.9
BG00129.0± 11.4
BG00234.0± 11.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0000
BG0010
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0002
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
Percentage of Participants With Adverse Events (AEs) and AEs of Special Interest
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
AEs of Special Interest were defined as: i.) elevated ALT/AST in combination with elevated bilirubin/clinical jaundice, ii.) suspected transmission of infectious agent by the study drug, iii.) severe injection site reactions, iv.) ALT elevation ≥10x ULN, v.) creatinine elevation ≥1.5x ULN or ≥50% from baseline.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Up to day 113
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
OG004
Part 1 - RO7062931 3.0 mg/kg
Participants received a single SC injection of 3.0 mg/kg RO7062931.
OG005
Part 1 - RO7062931 4.0 mg/kg
Participants received a single SC injection of 4.0 mg/kg RO7062931.
OG006
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
OG007
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG008
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
Units
Counts
Participants
OG0008
OG0018
OG0028
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG00075.0
OG00187.5
OG00237.5
OG003
Primary
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 1
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Screening, Days -1, 2, 8, 15, 29, 85
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Primary
Percentage of Participants With Laboratory Abnormalities Based on Hematology, Blood Chemistry, Coagulation, and Urinalysis Test Results - Part 2
Marked reference range has been predefined for each laboratory parameter. The marked reference range is broader than the standard reference range. Values falling outside the marked reference range that also represent a defined change from baseline will be considered marked laboratory abnormalities (i.e., potentially clinically relevant). If a baseline value is not available for a study subject, the midpoint of the standard reference range will be used as the study participant baseline value for the purposes of determining marked laboratory abnormalities.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Screening, Days -1, 2, 8, 15, 29, at discontinuation, Days 36, 43, 57, 85, 113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Primary
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 1
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF > 500 msec, or > 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single SC injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
Secondary
Maximum Plasma Concentration (Cmax) After Single Ascending Doses - Part 1
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol/L
Days 1-8
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
Secondary
Cmax After Multiple Ascending Doses - Part 2
Cmax values are the the peak plasma concentration reached after administration of RO7062931.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
mg/kg
Days 1-113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) After Single-Ascending Doses - Part 1
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Median
Full Range
Hours (h)
Days 1-8
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
Secondary
Tmax After Multiple Ascending Doses - Part 2
Tmax values are the amount of time to maximum concentration in plasma after administration of RO7062931.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Median
Full Range
Hours (h)
Days 1-113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) After Single-Ascending Doses - Part 1
AUC0-inf was calculated based on non-compartmental analysis.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*nmol/L
Days 1-8
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
Secondary
AUC0-inf After Multiple Ascending Doses - Part 2
AUC0-inf was calculated based on non-compartmental analysis.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
h*nmol/L
Days 1,22,29
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
Secondary
Area Under the Plasma Concentration-Time Curve From Time Zero Until the Last Quantifiable Time-Point (AUC0-last) After Single Ascending Doses - Part 1
AUC0-last was calculated based on non-compartmental analysis.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
(hr*nmol/L)
Days 1-8
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single SC injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
Secondary
AUC0-last After Multiple Ascending Doses - Part 2
AUC0-last was calculated based on non-compartmental analysis.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
hr*nmol/L
Days 1,22,29
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
Secondary
Terminal Elimination Half-Life (t1/2) After Single Ascending Doses - Part 1
T1/2 was calculated based on non-compartmental analysis.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours (h)
Days 1-8
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
Secondary
Terminal Elimination Half-Life (t1/2) After Multiple Ascending Doses - Part 2
T1/2 was calculated based on non-compartmental analysis.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Hours (h)
Days 1-113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
Secondary
Total Clearance (CL) After Single Ascending Doses - Part 1
Apparent oral clearance was calculated from Dose/AUCinf.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Days 1-8
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 4.0 mg/kg
Participants received a single SC injection of 4.0 mg/kg RO7062931.
OG004
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
Secondary
Total Clearance (CL) After Multiple Ascending Doses - Part 2
Apparent oral clearance was calculated from Dose/AUCinf.
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
L/h
Days 1-113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
Secondary
Volume of Distribution (Vss) After Single Ascending Doses - Part 1
Vss was calculated from dose/AUCinf
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters (L)
Days 1-8
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 2.0 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
OG004
Part 1 - RO7062931 4.0 mg/kg
Participants received a single SC injection of 4.0 mg/kg RO7062931.
Secondary
Volume of Distribution (Vss) After Multiple Ascending Doses - Part 2
Vss was calculated from dose/AUCinf
The PK analysis population included participants that did not significantly violate eligibility criteria and/or deviate significantly from the protocol. Participants with incomplete or unavailable data were excluded from analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
Liters (L)
Days 1-113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
Secondary
Cumulative Amount Excreted Unchanged in Urine (Ae) After Single Ascending Doses - Part 1
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Posted
Geometric Mean
Geometric Coefficient of Variation
pmol
Hours 0-4, 0-8, 0-12, and 0-24
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single SC injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
OG004
Part 1 - RO7062931 4.0 mg/kg
Secondary
Cumulative Amount Excreted Unchanged in Urine (Ae) After Multiple Ascending Doses - Part 2
Ae: cumulative amount of drug excreted in urine over a 24 hour period or over defined time periods linked to the pools of urine collected.
Posted
Geometric Mean
Geometric Coefficient of Variation
nmol
Days 1-113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
OG004
Part 2b - RO7062931 3.0 mg/kg QW
Secondary
Change From Baseline of Quantitative HBsAg (qHBsAg) (log10) After Multiple Ascending Doses - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Participants that did not complete planned treatment and/or discontinued from the study were not included in this end point.
Posted
Mean
Standard Deviation
IU/mL
Days 1-113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
Secondary
Summary of Maximum qHBsAg Decrease on Days 1-113 - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Participants that did not complete planned treatment and/or discontinued from the study were not included in this end point.
Posted
Mean
Standard Deviation
IU/mL
Day 1 - Day 113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
OG004
Secondary
Summary of Time to Maximum qHBsAg Decrease on Day 1-113 - Part 2
HBsAg is a viral parameter that can be affected by the action of RO7062931. A change from baseline in qHBsAg can indicate the drug's effect.
Participants that did not complete planned treatment and/or discontinued from the study were not included in this end point.
Posted
Median
Full Range
Days
Day 1 - Day 113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
OG004
Primary
Percentage of Participants With Electrocardiogram (ECG) Abnormalities Based on ECG Interpretation - Part 2
Participants were monitored for clinically-significant RO7062931-related ECG changes, defined as QTcF > 500 msec, or > 60 msec longer than the pre-dose baseline, within the first 48 hours post-dose.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Primary
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 1
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single SC injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Primary
Percentage of Participants With U-Wave Abnormalities Based on U-Wave Assessment - Part 1
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Day 1 (1,4,8,12h), Days 2 and 8, Follow Up Days 15, 29, 85
ID
Title
Description
OG000
Part 1 - RO7062931 0.1 mg/kg
Participants received a single SC injection of 0.1 mg/kg RO7062931.
OG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
OG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
OG003
Part 1 - RO7062931 2.0 mg/kg
Primary
Percentage of Participants With T-Wave Abnormalities Based on T-Wave Assessment - Part 2
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Primary
Percentage of Participants With U-Wave Based on U-Wave Assessment - Part 2
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Primary
Percentage of Participants With QTcF Values Between 450 Msec - 480 Msec - Part 2
Table entries provide the percentage of participants with abnormalities during treatment assessment. Abnormalities reported in participants with missing baseline values are included. Baseline is the Participant's last observation prior to initiation of study drug.
Safety population: All study subjects that received at least one dose of study medication, whether prematurely withdrawn from the study or not.
Posted
Number
Percentage of Participants
Day 1 (1,4,8h), Days 2,8,15,22 (1h and 8h), Day 23, Day 29 (1,4,8h), Day 30, Follow Up Days 36, 43, 50, 57, 78, 85, 106, 113
ID
Title
Description
OG000
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
OG001
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
OG002
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
OG003
Part 2b - RO7062931 3.0 mg/kg QW
Time Frame
Approximately 32 months
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and does not necessarily require a causal relationship with treatment. An adverse event can be any unfavorable and unintended sign, symptom, or disease temporally associated with use of a pharmaceutical product, whether or not considered related to the product. Preexisting conditions that worsen during a study are also considered adverse events.
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 - RO7062931 0.1 mg/kg
Participants received a single subcutaneous (SC) injection of 0.1 mg/kg RO7062931.
0
8
0
8
6
8
EG001
Part 1 - RO7062931 0.3 mg/kg
Participants received a single SC injection of 0.3 mg/kg RO7062931.
0
8
0
8
7
8
EG002
Part 1 - RO7062931 1.0 mg/kg
Participants received a single SC injection of 1.0 mg/kg RO7062931.
0
8
0
8
3
8
EG003
Part 1 - RO7062931 2.0 mg/kg
Participants received a single SC injection of 2.0 mg/kg RO7062931.
0
8
0
8
6
8
EG004
Part 1 - RO7062931 3.0 mg/kg
Participants received a single SC injection of 3.0 mg/kg RO7062931.
0
8
0
8
7
8
EG005
Part 1 - RO7062931 4.0 mg/kg
Participants received a single SC injection of 4.0 mg/kg RO7062931.
0
8
0
8
4
8
EG006
Part 1 - Placebo
Participants received a single SC injection of placebo matched to RO7062931.
0
12
0
12
7
12
EG007
Part 2a - RO7062931 0.5 mg/kg Q1M
Participants received two QM SC injections of 0.5 mg/kg RO7062931.
0
6
0
6
2
6
EG008
Part 2a - RO7062931 1.5 mg/kg Q1M
Participants received 2 QM SC injections of 1.5 mg/kg RO7062931.
0
7
0
7
6
7
EG009
Part 2a - RO7062931 3.0 mg/kg Q1M
Participants received 2 QM SC injections of 3.0 mg/kg RO7062931.
0
6
0
6
4
6
EG010
Part 2b - RO7062931 3.0 mg/kg QW
Participants received five QW SC injections of 3.0 mg/kg RO7062931.
0
14
0
14
10
14
EG011
Part 2b - RO7062931 3.0 mg/kg Q2W
Participants received three Q2W SC injections of 3.0 mg/kg RO7062931.
0
7
0
7
4
7
EG012
Part 2b - RO7062931 4.0 mg/kg QW
Participants received four QW SC injections of 4.0 mg/kg RO7062931.
0
4
0
4
3
4
EG013
Part 2 - Placebo
Participants received SC placebo matched to RO7062931 over a 4-week period.
0
15
0
15
8
15
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected8 at risk
EG0050 events0 affected8 at risk
EG0060 events0 affected12 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected6 at risk
EG0100 events0 affected14 at risk
EG0110 events0 affected7 at risk
EG0121 events1 affected4 at risk
EG0130 events0 affected15 at risk
Atrioventricular block first degree
Cardiac disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Photophobia
Eye disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Food poisoning
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Tongue ulceration
Gastrointestinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Catheter site bruise
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Catheter site thrombosis
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Chest discomfort
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Feeling hot
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Injection site haemorrhage
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Injection site reaction
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Thirst
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Vessel puncture site haematoma
General disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Chlamydial infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Laryngitis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Tinea versicolour
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0002 events2 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Clavicle feacture
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pulmonary contusion
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Skin abrasion
Injury, poisoning and procedural complications
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Transaminases increased
Investigations
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0022 events2 affected8 at risk
EG003
Joint stiffness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0002 events2 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dizziness postural
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected8 at risk
EG0012 events2 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Presyncope
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Sensory disturbance
Nervous system disorders
MedDRA 22.1
Non-systematic Assessment
EG0001 events1 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected8 at risk
EG003
Dry throat
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Dyspnoea exertional
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pigmentation disorder
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Pruritis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA 22.1
Non-systematic Assessment
EG0000 events0 affected8 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected8 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
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.