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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06384131
Other study ID # ABI-4334-102
Secondary ID 2024-511051-18
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date April 30, 2024
Est. completion date April 22, 2025

Study information

Verified date April 2024
Source Assembly Biosciences
Contact Assembly Biosciences
Phone 833-509-4583
Email clinicaltrials@assemblybio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 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-4334 or placebo.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 22, 2025
Est. primary completion date April 22, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Intervention

Drug:
ABI-4334
10 mg or 50 mg tablets for oral administration
Placebo
10 mg or 50 mg tablets for oral administration

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assembly Biosciences

Outcome

Type Measure Description Time frame Safety issue
Primary Primary Outcome Measure Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results Through end of study, up to 56 days
Secondary Maximum Plasma Concentration (Cmax) of ABI-4334 in subjects with cHBV Through treatment period, up to 28 days
Secondary Minimum Plasma Concentration (Cmin) of ABI-4334 in subjects with cHBV Through treatment period, up to 28 days
Secondary Area Under Plasma Concentration-Time Curve (AUC) of ABI-4334 in subjects with cHBV Through treatment period, up to 28 days
Secondary Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV Through treatment period, up to 28 days
Secondary Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV Through treatment period, up to 28 days
Secondary To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV Through treatment period, up to 28 days
Secondary Proportion of subjects with HBV DNA < lower limit of quantification (LLOQ) and/or limit of detection (LOD) Through treatment period, up to 28 days
Secondary Mean time elapsed to subjects achieving HBV DNA < LLOQ and/or LOD Through treatment period, up to 28 days
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