Clinical trial NCT06384131: A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 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-4334 in Subjects with Chronic Hepatitis B Virus Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Hepatitis B
Keywords: cHBV
HBV
Hepatitis B
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2024-04-25
Enrollment: 50
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-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.


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

Primary outcomes:
measure: To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses
timeFrame: Through end of study, up to 56 days
Secondary outcomes:
measure: To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
timeFrame: Through treatment period, up to 28 days
measure: To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV
timeFrame: Through treatment period, up to 28 days
measure: Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
timeFrame: Through treatment period, up to 28 days
measure: Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
timeFrame: Through treatment period, up to 28 days
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: ARENSIA Exploratory Medicine Cluj-Napoca
city: Chisinau
country: Moldova, Republic of
facility: ARENSIA Exploratory Medicine Chisinau
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research
city: Bucharest
country: Romania
facility: ARENSIA Exploratory Medicine S.R.L.
city: Cluj-Napoca
country: Romania
facility: ARENSIA Exploratory Medicine SRL
Study officials:
References: