A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection

Chronic Hepatitis B Clinical Trial

Official title:

A Randomized, Blinded, Placebo-Controlled Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection

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
• 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
• 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

Related Conditions & MeSH terms

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

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