NCT05414981

Brief Summary

This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-H3733 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-H3733 or placebo.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2022

Geographic Reach
6 countries

9 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

June 2, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 7, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

9 months

First QC Date

June 2, 2022

Last Update Submit

June 28, 2023

Conditions

Chronic Hepatitis B

Keywords

cHBVHBVHepatitis B

Outcome Measures

Primary Outcomes (1)

  • 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 (9)

  • Maximum Plasma Concentration (Cmax) of ABI-H3733 in subjects with cHBV

    Through treatment period, up to 28 days

  • Minimum Plasma Concentration (Cmin) of ABI-H3733 in subjects with cHBV

    Through treatment period, up to 28 days

  • Area Under Plasma Concentration-Time Curve (AUC) of ABI-H3733 in subjects with cHBV

    Through treatment period, up to 28 days

  • Time to Maximum Plasma Concentration (Tmax) of ABI-H3733 in subjects with cHBV

    Through treatment period, up to 28 days

  • Elimination half-life (t1/2) of ABI-H3733 in subjects with cHBV

    Through treatment period, up to 28 days

  • +4 more secondary outcomes

Study Arms (2)

ABI-H3733

ACTIVE COMPARATOR
Drug: ABI-H3733

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ABI-H3733DRUG

25 mg or 100 mg tablets for oral administration

ABI-H3733
PlaceboDRUG

25 mg or 100 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
  • Current or prior treatment for cHBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Diagnostic Consultative Center Aleksandrovska

Sofia, Sofia-Grad, 1431, Bulgaria

Location

Acibadem City Clinic Tokuda Hospital

Sofia, 1407, Bulgaria

Location

Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia

Sofia, 1606, Bulgaria

Location

University of Hong Kong

Hong Kong, Hong Kong

Location

ICS Arensia Exploratory Medicine Republican Clinical Hospital "Timofei Moșneaga"- Hospital

Chisinau, MD-2025, Moldova

Location

New Zealand Clinical Research

Grafton, Auckland, 1051, New Zealand

Location

Institute of Infectious Diseases - Hospital ARENSIA Exploratory Medicine Research Clinic National Institute of Infectious Diseases "Matei Bals"

Bucharest, 021105, Romania

Location

Clinical Trials and Research Centre, Singapore General Hospital

Singapore, 168753, Singapore

Location

National University Hospital

Singapore, Singapore

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
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 10, 2022

Study Start

August 7, 2022

Primary Completion

April 24, 2023

Study Completion

April 24, 2023

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)SG(2)BU(3)HK(1)NZ(1)MO(1)