A Study to Investigate Safety, Tolerability, Pharmacokine... | NCT05763576 | Trialant
NCT05763576
Sponsor
Hoffmann-La Roche
Status
Terminated
Last Update Posted
Jan 22, 2026Actual
Enrollment
60Actual
Phase
Phase 1
Conditions
Chronic Hepatitis B
Interventions
RO7565020
Placebo
Nucleos(t)ide analogue (NUC) treatment
Countries
United States
Hong Kong
New Zealand
South Korea
Spain
Taiwan
Thailand
Protocol Section
Identification Module
NCT ID
NCT05763576
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
BP44118
Secondary IDs
ID
Type
Description
Link
EU Trial Number
Registry Identifier
2022-502579-46-00
Brief Title
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
Official Title
A Phase I Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
Acronym
Not provided
Organization
Hoffmann-La RocheINDUSTRY
Status Module
Record Verification Date
Jan 2026
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The Sponsor decided to discontinue the development of RO7565020 and as a result the BP44118 study was terminated.
Expanded Access Info
No
Start Date
Apr 28, 2023Actual
Primary Completion Date
Dec 23, 2024Actual
Completion Date
Dec 23, 2024Actual
First Submitted Date
Feb 28, 2023
First Submission Date that Met QC Criteria
Feb 28, 2023
First Posted Date
Mar 10, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2025
Results First Submitted that Met QC Criteria
Jan 20, 2026
Results First Posted Date
Jan 22, 2026Actual
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
Jan 20, 2026
Last Update Posted Date
Jan 22, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Hoffmann-La RocheINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
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
This is a first in human (FIH), multi-center, dose-finding, and dose-escalation Phase I clinical study of RO7565020 to investigate the safety and tolerability and to characterize the pharmacokinetics and pharmacodynamics following single and/or multiple doses of RO7565020 in healthy participants and/or virologically suppressed participants with chronic hepatitis B (CHB).
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
60Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
RO7565020
Experimental
Drug: RO7565020
Drug: Nucleos(t)ide analogue (NUC) treatment
Placebo
Placebo Comparator
Other: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
RO7565020
Drug
RO7565020 will be administered by subcutaneous injection or intravenous infusion.
RO7565020
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part 1a: Number of Healthy Volunteers With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.
Up to approximately 40 weeks
Part 2a: Number of CHB Participants With AEs and SAEs
An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.
Up to approximately 32 weeks
Part 1a: Number of Healthy Volunteers With Adverse Events of Special Interest (AESI)
An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESI includes elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value in combination with either an elevated bilirubin value or clinical jaundice and suspected transmission of an infectious agent by the study treatment.
Secondary Outcomes
Measure
Description
Time Frame
Part 1a (SC Cohorts) and Part 2a: Time to Maximum Concentration (Tmax) of RO7565020
Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 1a (IV Cohorts): Tmax of RO7565020
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers:
Healthy participants
Body mass index (BMI) between 18 and 32 kg/m^2
CHB participants:
CHB infection (HBsAg-positive for >/= 6 months)
On NUC (ETV, TAF, or TDF) monotherapy for >/= 12 months
Liver biopsy, FibroScan, or equivalent test within the past 6 months demonstrating liver disease consistent with chronic HBV infection without evidence of bridging fibrosis or cirrhosis
BMI between 18 and 32 kg/m^2
Exclusion Criteria:
Healthy volunteers:
History of any clinically significant disease
Concomitant disease that could interfere with treatment or conduct of study
Use of any treatment within the 2 weeks or within 5 half-lives prior to first dosing (whichever is longer)
CHB participants:
Evidence of liver cirrhosis or decompensated liver disease
History or suspicion of hepatocellular carcinoma (HCC)
History or evidence of a medical condition associated with chronic liver disease other than HBV infection, or clinically significant and not adequately controlled non-hepatic disease
History of or currently receiving any systemic anti-neoplastic or immune-modulatory treatment within the 8 weeks prior to the first dosing or the expectation that such treatment will be needed at any time during the study.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
65 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Trials
Hoffmann-La Roche
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Quest Clinical Research
San Francisco
California
94115
United States
Queen Mary Hospital
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
The study consists of 3 parts- Part 1a: single-ascending dose (SAD) and Part 1b: multiple doses in healthy participants, Part 2 (a and b): SAD in participants with CHB, and Part 3: multiple doses in participants with CHB. No participants were enrolled in the Part 1b, Part 2b, and Part 3 as the study was terminated by the sponsor.
Recruitment Details
A total of 48 healthy participants (Part 1a) and 12 participants with chronic hepatitis B (CHB) virus infection (Part 2a) took part in the study across 10 investigative sites in Hong Kong, Thailand, New Zealand, Republic of Korea, United States, Spain, and Taiwan from 28 April 2023 to 23 December 2024.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part 1a Placebo
Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via subcutaneous (SC) injection or intravenous (IV) infusion on Day 1 of treatment period.
FG001
Part 1a Cohort 1
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_SAP
Yes
Yes
No
Study Protocol and Statistical Analysis Plan
May 15, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Bulgaria
France
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
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
Other
Matching placebo will be administered by subcutaneous injection or intravenous infusion.
Placebo
Nucleos(t)ide analogue (NUC) treatment
Drug
NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.
RO7565020
Up to approximately 40 weeks
Part 2a: Number of CHB Participants With AESI
An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESI includes elevated ALT or AST value in combination with either an elevated bilirubin value or clinical jaundice and suspected transmission of an infectious agent by the study treatment.
Up to approximately 32 weeks
Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253
Parts 1a and 2a: Maximum Serum Concentration (Cmax) of RO7565020
Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
Parts 1a and 2a: Area Under the Time-concentration Curve From Time 0 to Time of Last Sampling Point or Last Quantifiable Sample, Whichever Comes First (AUC0-last) of RO7565020
Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
Parts 1a and 2a: Area Under the Time-concentration Curve From Time 0 to Infinity (AUC0-inf) of RO7565020
Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
Parts 1a and 2a: Terminal Half-life (t1/2) of RO7565020
Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
Part 1a (IV Cohorts): Volume of Distribution (Vss) of RO7565020
Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197 and 253
Part 1a (IV Cohorts): Clearance (CL) of RO7565020
Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197 and 253
Part 1a (SC Cohorts) and Part 2a: Apparent Clearance (CL/F) of RO7565020
Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 1a (SC Cohorts) and Part 2a: Apparent Volume of Distribution (Vz/F) at Terminal Phase of RO7565020
Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)
IU/mL= international units per milliliter
Baseline, 4- and 8-hours post-dose on Day 1; subsequently on Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 2a: Maximum Reduction From Baseline in Serum HBsAg
Up to Day 169
Part 2a: Percentage of Participants With HBsAg Loss
Up to Day 169
Part 2a: Percentage of Participants With HBsAg Seroconversion
HBsAg seroconversion was defined as sustained loss of HBsAg and detection of anti-HBs antibody.
Up to Day 169
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline
At Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
Part 2a: Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline
HBeAg seroconversion was defined as sustained loss of HBeAg and detection of anti-HBe antibody.
Up to Day 169
Number of Participants With Anti-Drug Antibodies (ADAs) to RO7565020
The number of ADA-positive participants at baseline (baseline prevalence) and after drug administration was determined in participants exposed to RO7565020 (post-baseline). Participants were considered ADA positive if they had ADA negative or have missing data at baseline but develop an ADA response following study treatment administration (treatment-induced ADA response), or if they are ADA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold (e.g., ≥ 0.60-titer units) greater than the titer of the baseline sample (treatment enhanced ADA response).
Part 1a: Baseline and post-baseline (up to approximately 40 weeks); Part 2a: Baseline and post-baseline (up to approximately 32 weeks)
Hong Kong
Hong Kong
Prince of Wales Hospital
Shatin, New Territories
Hong Kong
New Zealand Clinical Research - Auckland
Auckland
1010
New Zealand
Hallym University Chuncheon Sacred Heart Hospital
Chuncheon
24253
South Korea
Hospital Alvaro Cunqueiro
Vigo
Pontevedra
36312
Spain
Chang Gung Medical Foundation Linkou Branch
Taoyuan City
333
Taiwan
Faculty of Medicine Siriraj Hospital
Bangkok
10700
Thailand
Maharaj Nakorn Chiang Mai Hospital
Chiang Mai
50200
Thailand
Healthy participants received a single dose of RO7565020, 70 milligrams (mg) as a SC injection on Day 1 of treatment period.
FG002
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
FG003
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
FG004
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
FG005
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
FG006
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as an SC injection on Day 1 of treatment period. Cohort 6 was a pharmacokinetic (PK) ethnicity bridging cohort between a global population and Chinese population.
FG007
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable nucleos(t)ide analogue (NUC) treatment received a single dose of RO7565020, 70 mg, as an SC injection on Day 1 of treatment period.
FG008
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as an SC injection on Day 1 of treatment period.
FG00012 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0056 subjects
FG0066 subjects
FG0076 subjects
FG0086 subjects
COMPLETED
FG00012 subjects
FG0016 subjects
FG0026 subjects
FG0036 subjects
FG0046 subjects
FG0055 subjects
FG0066 subjects
FG0074 subjects
FG0080 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0086 subjects
Type
Comment
Reasons
Study Terminated by Sponsor
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0086 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part 1a Placebo
Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via SC injection or IV infusion on Day 1 of treatment period.
BG001
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
BG002
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
BG003
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
BG004
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
BG005
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
BG006
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as an SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
BG007
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as an SC injection on Day 1 of treatment period.
BG008
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as an SC injection on Day 1 of treatment period.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG0016
BG0026
BG0036
BG0046
BG0056
BG0066
BG0076
BG0086
BG00960
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
BG00034.2± 9.3
BG00139.8± 7.9
BG00234.8± 12.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0006
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
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
Part 1a: Number of Healthy Volunteers With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.
Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Posted
Count of Participants
Participants
Up to approximately 40 weeks
ID
Title
Description
OG000
Part 1a Placebo
Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via SC injection or IV infusion on Day 1 of treatment period.
OG001
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
OG002
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG003
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG004
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG005
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
OG006
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
Units
Counts
Participants
OG00012
OG0016
OG0026
OG003
Title
Denominators
Categories
AEs
Title
Measurements
OG0006
OG0014
OG0025
OG003
Primary
Part 2a: Number of CHB Participants With AEs and SAEs
An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is any significant hazard, contraindication, or side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is medically significant or requires intervention.
Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Posted
Count of Participants
Participants
Up to approximately 32 weeks
ID
Title
Description
OG000
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG001
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Primary
Part 1a: Number of Healthy Volunteers With Adverse Events of Special Interest (AESI)
An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESI includes elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value in combination with either an elevated bilirubin value or clinical jaundice and suspected transmission of an infectious agent by the study treatment.
Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Posted
Count of Participants
Participants
Up to approximately 40 weeks
ID
Title
Description
OG000
Part 1a Placebo
Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via SC injection or IV infusion on Day 1 of treatment period.
OG001
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
Primary
Part 2a: Number of CHB Participants With AESI
An AE was 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 AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptoms, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AESI includes elevated ALT or AST value in combination with either an elevated bilirubin value or clinical jaundice and suspected transmission of an infectious agent by the study treatment.
Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
Posted
Count of Participants
Participants
Up to approximately 32 weeks
ID
Title
Description
OG000
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG001
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Secondary
Part 1a (SC Cohorts) and Part 2a: Time to Maximum Concentration (Tmax) of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample. Overall number analyzed is the number of participants with data available for analysis.
Posted
Median
Full Range
day
Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
ID
Title
Description
OG000
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
OG001
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG002
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG003
Part 1a Cohort 6
Secondary
Part 1a (IV Cohorts): Tmax of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample.
Posted
Median
Full Range
hours
Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253
ID
Title
Description
OG000
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG001
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
Units
Counts
Participants
OG000
Secondary
Parts 1a and 2a: Maximum Serum Concentration (Cmax) of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
micrograms per milliliter (μg/mL)
Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
ID
Title
Description
OG000
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
OG001
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG002
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG003
Part 1a Cohort 4
Secondary
Parts 1a and 2a: Area Under the Time-concentration Curve From Time 0 to Time of Last Sampling Point or Last Quantifiable Sample, Whichever Comes First (AUC0-last) of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*μg/mL
Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
ID
Title
Description
OG000
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
OG001
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG002
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG003
Part 1a Cohort 4
Secondary
Parts 1a and 2a: Area Under the Time-concentration Curve From Time 0 to Infinity (AUC0-inf) of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
day*μg/mL
Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
ID
Title
Description
OG000
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
OG001
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG002
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG003
Secondary
Parts 1a and 2a: Terminal Half-life (t1/2) of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample. Overall number analyzed is the number of participants with data available for analysis.
Posted
Median
Full Range
day
Both Part 1a & 2a Cohorts: Predose, 1, 4, 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 29, 57, 85, & 141. Additionally, Part 1a: Days 21, 197, & 253; Part 2a: Days 22, 113, & 169; IV Cohorts: 0.08 hours after start of infusion, Days 21, 197, & 253
ID
Title
Description
OG000
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
OG001
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG002
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG003
Part 1a Cohort 4
Secondary
Part 1a (IV Cohorts): Volume of Distribution (Vss) of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters
Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197 and 253
ID
Title
Description
OG000
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG001
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
Units
Counts
Participants
OG000
Secondary
Part 1a (IV Cohorts): Clearance (CL) of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
milliliter/hour (mL/h)
Predose, 0.08, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197 and 253
ID
Title
Description
OG000
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG001
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
Units
Counts
Participants
OG000
Secondary
Part 1a (SC Cohorts) and Part 2a: Apparent Clearance (CL/F) of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
mL/h
Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
ID
Title
Description
OG000
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
OG001
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG002
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG003
Part 1a Cohort 6
Secondary
Part 1a (SC Cohorts) and Part 2a: Apparent Volume of Distribution (Vz/F) at Terminal Phase of RO7565020
PK-evaluable population included all participants who received at least one dose of study treatment and who had data from at least one postdose sample. Overall number analyzed is the number of participants with data available for analysis.
Posted
Geometric Mean
Geometric Coefficient of Variation
liters
Part 1a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 21, 29, 57, 85, 141, 197, and 253. Part 2a: Predose, 1, 4, and 8 hours post-dose on Day 1; Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
ID
Title
Description
OG000
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
OG001
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG002
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG003
Part 1a Cohort 6
Secondary
Part 2a: Change From Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)
IU/mL= international units per milliliter
Pharmacodynamic (PD) population included all participants with CHB who received at least one dose of study treatment. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Mean
Standard Deviation
log10 IU/mL
Baseline, 4- and 8-hours post-dose on Day 1; subsequently on Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
ID
Title
Description
OG000
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG001
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
Secondary
Part 2a: Maximum Reduction From Baseline in Serum HBsAg
PD population included all participants with CHB who received at least one dose of study treatment.
Posted
Mean
Standard Deviation
log10 IU/mL
Up to Day 169
ID
Title
Description
OG000
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG001
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG000
Secondary
Part 2a: Percentage of Participants With HBsAg Loss
PD population included all participants with CHB who received at least one dose of study treatment.
Posted
Number
percentage of participants
Up to Day 169
ID
Title
Description
OG000
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG001
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG000
Secondary
Part 2a: Percentage of Participants With HBsAg Seroconversion
HBsAg seroconversion was defined as sustained loss of HBsAg and detection of anti-HBs antibody.
PD population included all participants with CHB who received at least one dose of study treatment.
Posted
Number
percentage of participants
Up to Day 169
ID
Title
Description
OG000
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG001
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG000
Secondary
Part 2a: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline
PD population included all participants with CHB who received at least one dose of study treatment. Overall Number analyzed included participants who were HBeAg-positive at baseline.
Posted
Number
percentage of participants
At Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
ID
Title
Description
OG000
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG001
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG000
Secondary
Part 2a: Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline
HBeAg seroconversion was defined as sustained loss of HBeAg and detection of anti-HBe antibody.
PD population included all participants with CHB who received at least one dose of study treatment. Overall number analyzed included participants who were HBeAg-positive at baseline.
Posted
Number
percentage of participants
Up to Day 169
ID
Title
Description
OG000
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG001
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Anti-Drug Antibodies (ADAs) to RO7565020
The number of ADA-positive participants at baseline (baseline prevalence) and after drug administration was determined in participants exposed to RO7565020 (post-baseline). Participants were considered ADA positive if they had ADA negative or have missing data at baseline but develop an ADA response following study treatment administration (treatment-induced ADA response), or if they are ADA positive at baseline and the titer of one or more post-baseline samples is at least 4-fold (e.g., ≥ 0.60-titer units) greater than the titer of the baseline sample (treatment enhanced ADA response).
Immunogenicity population included participants who had at least one ADA assessment and analyzed according to the treatment they actually received. Number analyzed is the number of participants with data available for analysis at the specified timepoint.
Posted
Count of Participants
Participants
Part 1a: Baseline and post-baseline (up to approximately 40 weeks); Part 2a: Baseline and post-baseline (up to approximately 32 weeks)
ID
Title
Description
OG000
Part 1a Placebo
Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via SC injection or IV infusion on Day 1 of treatment period.
OG001
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
Time Frame
Part 1a: Up to approximately 40 weeks Part 2a: Up to approximately 32 weeks
Description
Safety population included all participants randomized/assigned to study treatment and who received at least one dose of the study treatment, whether prematurely withdrawn from the study or not.
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 1a Placebo
Healthy participants received a single dose of placebo, matched to each dose level of RO7565020, via SC injection or IV infusion on Day 1 of treatment period.
0
12
0
12
6
12
EG001
Part 1a Cohort 1
Healthy participants received a single dose of RO7565020, 70 mg as a SC injection on Day 1 of treatment period.
0
6
0
6
4
6
EG002
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
0
6
0
6
5
6
EG003
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
0
6
0
6
4
6
EG004
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
0
6
1
6
6
6
EG005
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
0
6
0
6
6
6
EG006
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
0
6
0
6
1
6
EG007
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as an SC injection on Day 1 of treatment period.
0
6
0
6
2
6
EG008
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as an SC injection on Day 1 of treatment period.
0
6
0
6
3
6
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0041 events1 affected6 at risk
EG0050 events0 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Palpitations
Cardiac disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG0030 events0 affected6 at risk
EG0040 events0 affected6 at risk
EG0051 events1 affected6 at risk
EG0060 events0 affected6 at risk
EG0070 events0 affected6 at risk
EG0080 events0 affected6 at risk
Ear pain
Ear and labyrinth disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Eustachian tube dysfunction
Ear and labyrinth disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypoacusis
Ear and labyrinth disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cataract
Eye disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Abdominal pain lower
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Infrequent bowel movements
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Catheter site bruise
General disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Chest pain
General disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fatigue
General disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Influenza like illness
General disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
COVID-19
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0011 events1 affected6 at risk
EG0022 events2 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Oral herpes
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0002 events1 affected12 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0022 events1 affected6 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA version 27.1
Systematic Assessment
EG0002 events2 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0011 events1 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin laceration
Injury, poisoning and procedural complications
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0011 events1 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0013 events2 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Migraine
Nervous system disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Somnolence
Nervous system disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Syncope
Nervous system disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Endometriosis
Reproductive system and breast disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Intermenstrual bleeding
Reproductive system and breast disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vaginal discharge
Reproductive system and breast disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0021 events1 affected6 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Skin striae
Skin and subcutaneous tissue disorders
MedDRA version 27.1
Systematic Assessment
EG0001 events1 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 27.1
Systematic Assessment
EG0000 events0 affected12 at risk
EG0010 events0 affected6 at risk
EG0020 events0 affected6 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.
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG003
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG004
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG005
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
OG006
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
Units
Counts
Participants
OG00012
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
Units
Counts
Participants
OG0006
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
OG004
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG005
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0045
OG0056
Title
Denominators
Categories
Title
Measurements
OG00014(2 to 56)
OG00117(6.99 to 21)
OG00210.5(3 to 28)
OG00310.7(6.06 to 29.1)
OG0047.01(3.03 to 21)
OG00510.5(6.96 to 15)
6
OG0016
Title
Denominators
Categories
Title
Measurements
OG0002.12(2.12 to 6.3)
OG0012.12(2.12 to 2.17)
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG004
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
OG005
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
OG006
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG007
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0065
OG0076
Title
Denominators
Categories
Title
Measurements
OG0004.99± 52.1
OG00114.4± 66.0
OG00229.4± 37.1
OG003165± 18.6
OG004587± 27.6
OG00527.7± 43.3
OG0062.96± 46.5
OG00718.2± 45.7
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG004
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
OG005
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
OG006
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG007
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG0006
OG0016
OG0026
OG0036
OG0046
OG0056
OG0066
OG0076
Title
Denominators
Categories
Title
Measurements
OG000559± 42.0
OG0011630± 50.0
OG0023390± 33.8
OG0036630± 19.6
OG00424800± 17.0
OG0052960± 33.4
OG00659.9± 575.4
OG007898± 121.2
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG004
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
OG005
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
OG006
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG007
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG0006
OG0011
OG0024
OG0032
OG0042
OG0053
OG0063
OG0074
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGeometric mean (GM) and Geometric coefficient of variation were not available because, based on Roche internal non-compartmental analysis (NCA) guiding principles (version 4.0), these could only be provided when the terminal phase constant (lambda\_z) was appropriately determined and/or the extrapolated percentage of AUC0-inf was less than 20%. Data is not available as neither of these conditions were met for this cohort.
OG0012180± NAGeometric coefficient of variation was not estimable for one participant.
OG0023660± 24.4
OG0038450± 10.2
OG00430700± 26.7
OG0052900± 25.7
OG006172± 45.3
OG007792± 183.9
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG004
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
OG005
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
OG006
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG007
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG0006
OG0011
OG0024
OG0032
OG0042
OG0053
OG0063
OG0074
Title
Denominators
Categories
Title
Measurements
OG000NA(NA to NA)Median and full range were not available because, based on Roche internal NCA guiding principles (version 4.0), these could only be provided when the terminal phase constant (lambda\_z) was appropriately determined and/or the extrapolated percentage of AUC0-inf was less than 20%. Data is not available as neither of these conditions were met for this cohort.
OG00188(88 to 88)
OG00288.3(80.1 to 92.3)
OG00383.3(80.4 to 86.2)
OG00494.8(88.9 to 101)
OG00578.2(71.6 to 86.2)
OG00613.6(4.69 to 29.6)
OG00719.8(4.8 to 51.7)
2
OG0012
Title
Denominators
Categories
Title
Measurements
OG0005.14± 2.5
OG0016.19± 37.3
2
OG0012
Title
Denominators
Categories
Title
Measurements
OG0001.78± 10.2
OG0012.03± 26.7
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
OG004
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG005
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG0006
OG0011
OG0024
OG0033
OG0043
OG0054
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGM and Geometric coefficient of variation were not available because, based on Roche internal NCA guiding principles (version 4.0), these could only be provided when the terminal phase constant (lambda\_z) was appropriately determined and/or the extrapolated percentage of AUC0-inf was less than 20%. Data is not available as neither of these conditions were met for this cohort.
OG0014.39± NAGeometric coefficient of variation was not estimable for one participant.
OG0024.1± 24.4
OG0035.18± 25.7
OG00416.9± 45.3
OG00512.1± 183.9
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
OG004
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG005
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.
Units
Counts
Participants
OG0006
OG0011
OG0024
OG0033
OG0043
OG0054
Title
Denominators
Categories
Title
Measurements
OG000NA± NAGM and Geometric coefficient of variation were not available because, based on Roche internal NCA guiding principles (version 4.0), these could only be provided when the terminal phase constant (lambda\_z) was appropriately determined and/or the extrapolated percentage of AUC0-inf was less than 20%. Data is not available as neither of these conditions were met for this cohort.
OG00113.4± NAGeometric coefficient of variation was not estimable for one participant.
OG00212.4± 26.8
OG00314.1± 18.3
OG0047.23± 60.8
OG0057.33± 35.0
OG0006
OG0016
Title
Denominators
Categories
Baseline
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG0002.36± 0.73
OG0012.63± 0.38
Change at 4 h Post-dose, Day 1
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000-0.20± 0.09
OG001
Change at 8 h Post-dose, Day 1
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000-0.44± 0.24
OG001
Change at Day 2
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000-0.88± 0.29
OG001
Change at Day 3
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000-0.99± 0.29
OG001
Change at Day 4
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000-1.03± 0.29
OG001
Change at Day 8
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000-1.38± 0.54
OG001
Change at Day 15
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000-1.17± 0.56
OG001
Change at Day 22
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000-1.04± 0.58
OG001
Change at Day 29
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000-1.01± 0.57
OG001
Change at Day 57
ParticipantsOG0005
ParticipantsOG0016
Title
Measurements
OG000-0.68± 0.60
OG001
Change at Day 85
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000-0.51± 0.57
OG001
Change at Day 113
ParticipantsOG0005
ParticipantsOG0010
Title
Measurements
OG000-0.58± 0.56
Change at Day 141
ParticipantsOG0005
ParticipantsOG0010
Title
Measurements
OG000-0.54± 0.53
Change at Day 169
ParticipantsOG0006
ParticipantsOG0016
Title
Measurements
OG000-0.29± 0.56
OG001
6
OG0016
Title
Denominators
Categories
Title
Measurements
OG000-1.39± 0.471
OG001-1.44± 0.288
6
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
6
OG0016
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
1
OG0012
Title
Denominators
Categories
Day 2
Title
Measurements
OG0000
OG0010
Day 3
Title
Measurements
OG0000
OG0010
Day 4
Title
Measurements
OG0000
OG0010
Day 8
Title
Measurements
OG0000
OG00150.0
Day 15
Title
Measurements
OG0000
OG00150.0
Day 22
Title
Measurements
OG0000
OG00150.0
Day 29
Title
Measurements
OG0000
OG00150.0
Day 57
Title
Measurements
OG0000
OG00150.0
Day 85
Title
Measurements
OG0000
OG0010
Day 113
Title
Measurements
OG0000
OG0010
Day 141
Title
Measurements
OG0000
OG0010
Day 169
Title
Measurements
OG0000
OG00150.0
1
OG0012
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG002
Part 1a Cohort 2
Healthy participants received a single dose of RO7565020, 230 mg as a SC injection on Day 1 of treatment period.
OG003
Part 1a Cohort 3
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period.
OG004
Part 1a Cohort 4
Healthy participants received a single dose of RO7565020, 360 mg as an IV infusion on Day 1 of treatment period.
OG005
Part 1a Cohort 5
Healthy participants received a single dose of RO7565020, 1500 mg as an IV infusion on Day 1 of treatment period.
OG006
Part 1a Cohort 6
Healthy participants received a single dose of RO7565020, 360 mg as a SC injection on Day 1 of treatment period. Cohort 6 was a PK ethnicity bridging cohort between a global population and Chinese population.
OG007
Part 2a Cohort 1
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 70 mg, as a SC injection on Day 1 of treatment period.
OG008
Part 2a Cohort 2
Participants with CHB who were virologically suppressed with stable NUC treatment received a single dose of RO7565020, 230 mg, as a SC injection on Day 1 of treatment period.