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

Sponsor

Hoffmann-La Roche (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05763576

Collaborator

(none)

110

Enrollment

Arms

45.2

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Drug: RO7565020 Other: Placebo Drug: Nucleos(t)ide analogue (NUC) treatment	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 28, 2023

Anticipated Primary Completion Date :

Feb 1, 2027

Anticipated Study Completion Date :

Feb 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.
Placebo Comparator: Placebo	Other: Placebo Matching placebo will be administered by subcutaneous injection or intravenous infusion.

Arm

Intervention/Treatment

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.

Placebo Comparator: Placebo

Other: Placebo

Matching placebo will be administered by subcutaneous injection or intravenous infusion.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.