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

Hoffmann-La Roche12 sites in 8 countries60 target enrollmentApril 28, 2023

ConditionsChronic Hepatitis B

InterventionsRO7565020 Nucleos(t)ide analogue (NUC) treatment Placebo

DrugsRO7565020 Nucleos(t)ide analogue (NUC) treatment

Overview

Phase: Phase 1
Intervention: RO7565020
Conditions: Chronic Hepatitis B
Sponsor: Hoffmann-La Roche
Enrollment: 60
Locations: 12
Primary Endpoint: Percentage of Healthy Volunteers With Adverse Events
Status: Terminated
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

April 28, 2023

End Date

December 23, 2024

Last Updated

3 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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.

Arms & Interventions

RO7565020

Intervention: RO7565020

RO7565020

Intervention: Nucleos(t)ide analogue (NUC) treatment

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Percentage of Healthy Volunteers With Adverse Events

Time Frame: Up to 104 weeks

Percentage of Participants With Chronic Hepatitis B With Adverse Events

Time Frame: Up to 104 weeks

Secondary Outcomes

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)