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

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: Recruiting
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: RO7565020; Drug: Nucleos(t)ide analogue (NUC) treatment; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Reference Study ID Number: BP44118 https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S. Only); Email: global-roche-genentech-trials@gene.com

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1407
    • Recruiting
    • Acibadem City Clinic Tokuda Hospital Ead
• France
  • Clichy cedex, France, 92110
    • Recruiting
    • Hopital Beaujon
  • Paris, France, 75102
    • Recruiting
    • Hopital Saint-Antoine
• Hong Kong
  • Hong Kong, Hong Kong, 999077
    • Recruiting
    • Queen Mary Hospital
  • Shatin, New Territories, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
• Korea, Republic of
  • Chuncheon, Korea, Republic of, 24253
    • Recruiting
    • Hallym University Chuncheon Sacred Heart Hospital
  • Seoul, Korea, Republic of, 05505
    • Recruiting
    • Asan Medical Center
• New Zealand
  • Auckland, New Zealand, 1010
    • Recruiting
    • New Zealand Clinical Research - Auckland
• Spain
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Recruiting
      • Hospital Álvaro Cunqueiro
• Taiwan
  • Taoyuan City, Taiwan, 333
    • Recruiting
    • Chang Gung Medical Foundation Linkou Branch
• Thailand
  • Bangkok, Thailand, 10700
    • Recruiting
    • Faculty of Medicine Siriraj Hospital
  • Chiang Mai, Thailand, 50200
    • Recruiting
    • Maharaj Nakorn Chiang Mai Hospital
• United States
  • California
    • Rialto, California, United States, 92377
      • Recruiting
      • Inland Empire Liver Foundation
    • San Francisco, California, United States, 94115
      • Recruiting
      • Quest Clinical Research

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Percentage of Healthy Volunteers With Adverse Events	Up to 104 weeks
Percentage of Participants With Chronic Hepatitis B With Adverse Events	Up to 104 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Serum Concentrations of RO7565020	Up to 104 weeks
Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)	Up to 104 weeks
Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints	Up to 104 weeks
Percentage of Participants With HBsAg Loss	Up to 104 weeks
Percentage of Participants With HBsAg Seroconversion	Up to 104 weeks
Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline	Up to 104 weeks
Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline	Up to 104 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Chronic Disease; Hepatitis B; Hepatitis; Hepatitis A; Virus Diseases; Hepatitis B, Chronic; Hepatitis, Chronic; Herpesviridae Infections
• Other Study ID Numbers: BP44118; EU Trial Number (Registry Identifier: 2022-502579-46-00)

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