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

NCT06384131 — Phase 1, Completed, 20 participants, Assembly Biosciences

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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

Registry	NCT06384131
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	20 (Actual)
Sponsor	Assembly Biosciences (Industry)
Conditions	Chronic Hepatitis B
Interventions	ABI-4334, Placebo (Drug)
Dates	start 2024-06-04, primary completion 2025-04-15, completion 2025-05-14, first posted 2024-04-25, last updated 2025-07-23
Locations	2 sites in Moldova, New Zealand

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
ABI-4334	Active comparator	Drug: ABI-4334
Placebo	Placebo comparator	Drug: Placebo

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

+Outcome measures

Primary outcomes

To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses [Through end of study, up to 56 days]: Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results

Secondary outcomes

To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV [Through treatment period, up to 28 days]: Noncompartmental plasma PK parameters
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334 [Through treatment period, up to 28 days]: Mean change in log10 HBV DNA between Baseline and Day 28
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV [Through treatment period, up to 28 days]: Area Under Plasma Concentration-Time Curve (AUC) of ABI-4334 in subjects with cHBV
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV [Through treatment period, up to 28 days]: Time to Maximum Plasma Concentration (Tmax) of ABI-4334 in subjects with cHBV
Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV [Through treatment period, up to 28 days]
Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV [Through treatment period, up to 28 days]: To evaluate the changes in HBV DNA (IU/mL or Log IU/mL) in subjects with cHBV
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334 [Through treatment period, up to 28 days]: Proportion of subjects with HBV DNA < lower limit of quantification (LLOQ) and/or limit of detection (LOD)
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334 [Through treatment period, up to 28 days]: Mean time elapsed to subjects achieving HBV DNA < LLOQ and/or LOD

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (2)

Facility	City	Country	Status
ARENSIA Exploratory Medicine Chisinau	Chisinau	Moldova
New Zealand Clinical Research	Auckland	New Zealand