A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection

January 20, 2026 updated by: Hoffmann-La Roche

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Shatin, New Territories, Hong Kong
        • Prince of Wales Hospital
  • New Zealand
      • Auckland, New Zealand, 1010
        • New Zealand Clinical Research - Auckland
  • South Korea
      • Chuncheon, South Korea, 24253
        • Hallym University Chuncheon Sacred Heart Hospital
  • Spain
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36312
        • Hospital Álvaro Cunqueiro
  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation Linkou Branch
  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital
      • Chiang Mai, Thailand, 50200
        • Maharaj Nakorn Chiang Mai Hospital
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Quest Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Other: Placebo
Matching placebo will be administered by subcutaneous injection or intravenous infusion.
Experimental: RO7565020
Drug: RO7565020
RO7565020 will be administered by subcutaneous injection or intravenous infusion.
Drug: Nucleos(t)ide analogue (NUC) treatment
NUC treatment, including tenofovir disoproxil fumarate (TDF), tenofovir alafenamide (TAF), or entecavir (ETV), will be administered orally per local prescribing information.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Part 1a: Number of Healthy Volunteers With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to approximately 40 weeks
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
Time Frame: Up to approximately 32 weeks
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)
Time Frame: Up to approximately 40 weeks
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.
Up to approximately 40 weeks
Part 2a: Number of CHB Participants With AESI
Time Frame: Up to approximately 32 weeks
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

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Part 1a (SC Cohorts) and Part 2a: Time to Maximum Concentration (Tmax) of RO7565020
Time Frame: 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: 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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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: 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
Time Frame: 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: 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)
Time Frame: 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
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
Time Frame: Up to Day 169
Up to Day 169
Part 2a: Percentage of Participants With HBsAg Loss
Time Frame: Up to Day 169
Up to Day 169
Part 2a: Percentage of Participants With HBsAg Seroconversion
Time Frame: Up to Day 169
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
Time Frame: At Days 2, 3, 4, 8, 15, 22, 29, 57, 85, 113, 141, and 169
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
Time Frame: Up to Day 169
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
Time Frame: Part 1a: Baseline and post-baseline (up to approximately 40 weeks); Part 2a: Baseline and post-baseline (up to approximately 32 weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 28, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP44118
  • EU trial number (Other Identifier: 2023-510333-28-00)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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