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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763576
• Other study ID #: BP44118
• Secondary ID: EU Trial Number
• Status: Recruiting
• Phase: Phase 1
• Start date: April 28, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: June 2024
• Source: Hoffmann-La Roche
• Contact: Reference Study ID Number: BP44118 https://forpatients.roche.com
• Phone: 888-662-6728 (U.S. Only)
• Email: global-roche-genentech-trials[@]gene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Herpesviridae Infections
• Virus Diseases

Intervention

Drug:
• RO7565020
RO7565020 will be administered by subcutaneous injection or intravenous infusion.

Other:
• Placebo
Matching placebo 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.

Locations

Country	Name	City	State
Bulgaria	Acibadem City Clinic Tokuda Hospital Ead	Sofia
France	Hôpital Beaujon	Clichy cedex
France	Hôpital Saint-Antoine	Paris
Hong Kong	Queen Mary Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Shatin, New Territories
Korea, Republic of	Hallym University Chuncheon Sacred Heart Hospital	Chuncheon
Korea, Republic of	Asan Medical Center	Seoul
New Zealand	New Zealand Clinical Research - Auckland	Auckland
Spain	Hospital Alvaro Cunqueiro	Vigo	Pontevedra
Taiwan	Chang Gung Medical Foundation Linkou Branch	Taoyuan City
Thailand	Faculty of Medicine Siriraj Hospital	Bangkok
Thailand	Maharaj Nakorn Chiang Mai Hospital	Chiang Mai
United States	Inland Empire Liver Foundation	Rialto	California
United States	Quest Clinical Research	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Bulgaria,  France,  Hong Kong,  Korea, Republic of,  New Zealand,  Spain,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Healthy Volunteers With Adverse Events		Up to 104 weeks
Primary	Percentage of Participants With Chronic Hepatitis B With Adverse Events		Up to 104 weeks
Secondary	Serum Concentrations of RO7565020		Up to 104 weeks
Secondary	Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)		Up to 104 weeks
Secondary	Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints		Up to 104 weeks
Secondary	Percentage of Participants With HBsAg Loss		Up to 104 weeks
Secondary	Percentage of Participants With HBsAg Seroconversion		Up to 104 weeks
Secondary	Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline		Up to 104 weeks
Secondary	Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline		Up to 104 weeks