NCT06384131

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2024

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 4, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2025

Completed
Last Updated

July 23, 2025

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

April 22, 2024

Last Update Submit

July 18, 2025

Conditions

Chronic Hepatitis B

Keywords

cHBVHBVHepatitis B

Outcome Measures

Primary Outcomes (1)

  • To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses

    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 Outcomes (8)

  • 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

  • Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334

    Through treatment period, up to 28 days

  • 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

  • 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

  • Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV

    Through treatment period, up to 28 days

  • +3 more secondary outcomes

Study Arms (2)

ABI-4334

ACTIVE COMPARATOR
Drug: ABI-4334

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ABI-4334DRUG

10 mg or 50 mg tablets for oral administration

ABI-4334
PlaceboDRUG

10 mg or 50 mg tablets for oral administration

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Chronic hepatitis B infection, defined as HBV infection for ≥ 6 months documented
  • Treatment-naïve or off-antiviral therapy for ≥ 24 weeks prior to Screening
  • Lack of bridging fibrosis or cirrhosis

You may not qualify if:

  • 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)
  • History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
  • Clinically significant diseases or conditions
  • History of hepatocellular carcinoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ARENSIA Exploratory Medicine Chisinau

Chisinau, Moldova

Location

New Zealand Clinical Research

Auckland, New Zealand

Location

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Triple (Participant, Care Provider, Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2024

First Posted

April 25, 2024

Study Start

June 4, 2024

Primary Completion

April 15, 2025

Study Completion

May 14, 2025

Last Updated

July 23, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)NZ(1)