Clinical trial NCT05763576: A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7565020 in Healthy Participants and in Participants With Chronic Hepatitis B Virus Infection
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2023-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Percentage of Healthy Volunteers With Adverse Events
timeFrame: Up to 104 weeks
measure: Percentage of Participants With Chronic Hepatitis B With Adverse Events
timeFrame: Up to 104 weeks
Secondary outcomes:
measure: Serum Concentrations of RO7565020
timeFrame: Up to 104 weeks
measure: Change from Baseline in Serum Quantitative Hepatitis B Surface Antigen (HBsAg)
timeFrame: Up to 104 weeks
measure: Maximum Reduction from Baseline of Serum HBsAg Across All Timepoints
timeFrame: Up to 104 weeks
measure: Percentage of Participants With HBsAg Loss
timeFrame: Up to 104 weeks
measure: Percentage of Participants With HBsAg Seroconversion
timeFrame: Up to 104 weeks
measure: Percentage of Participants With Hepatitis B e Antigen (HBeAg) Loss Among HBeAg-positive Participants at Baseline
timeFrame: Up to 104 weeks
measure: Percentage of Participants With HBeAg Seroconversion Among HBeAg-positive Participants at Baseline
timeFrame: Up to 104 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Shatin, New Territories
country: Hong Kong
facility: Prince of Wales Hospital
city: Chuncheon
country: Korea, Republic of
facility: Hallym University Chuncheon Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research - Auckland
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
city: Taoyuan City
country: Taiwan
facility: Chang Gung Medical Foundation Linkou Branch
city: Xitun Dist.
country: Taiwan
facility: Taichung Veterans General Hospital
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: