Clinical trial NCT05414981: A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
Official title: A Randomized, Blinded, Placebo-Controlled, Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Keywords: cHBV
HBV
Hepatitis B
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2022-06-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-H3733 or placebo.


Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) ≥ 18.0 and \< 35.0 kg/m(2), where BMI = weight (kg)/(height \[m\])(2) with a minimum body weight of 45 kg.
2. Chronic hepatitis B infection, defined as HBV infection for ≥6 months documented
3. Treatment-naïve or off-antiviral therapy for ≥24 weeks prior to Screening
4. Lack of bridging fibrosis or cirrhosis

Exclusion Criteria:

1. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
2. History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
3. Clinically significant diseases or conditions
4. History of hepatocellular carcinoma
5. Current or prior treatment for cHBV

Primary outcomes:
measure: Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
timeFrame: Through end of study, up to 56 days
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: To evaluate the effect of food on Cmax of ABI-H3733 in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: To evaluate the effect of food on AUC of ABI-H3733 in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: To evaluate the effect of food on the proportion of subjects with AEs, premature discontinuation due to AEs and abnormal laboratory results
timeFrame: Through treatment period, up to 28 days
measure: To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV by Quantitative PCR
timeFrame: Through treatment period, up to 28 days
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Aleksandrovska
state: Sofia City
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital
city: Sofia
country: Bulgaria
facility: Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
city: Hong Kong
country: Hong Kong
facility: University of Hong Kong
city: Chisinau
country: Moldova, Republic of
facility: ICS Arensia Exploratory Medicine Republican Clinical Hospital "Timofei Moșneaga"- Hospital
city: Grafton
country: New Zealand
facility: New Zealand Clinical Research
state: Auckland
city: Bucharest
country: Romania
facility: Institute of Infectious Diseases - Hospital ARENSIA Exploratory Medicine Research Clinic National Institute of Infectious Diseases "Matei Bals"
city: Singapore
country: Singapore
facility: Clinical Trials and Research Centre, Singapore General Hospital
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
References: