Status:
COMPLETED
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
Lead Sponsor:
Assembly Biosciences
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 (cHB...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2023
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05414981
Start Date
August 7 2022
End Date
April 24 2023
Last Update
June 29 2023
Active Locations (9)
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1
Diagnostic Consultative Center Aleksandrovska
Sofia, Sofia-Grad, Bulgaria, 1431
2
Acibadem City Clinic Tokuda Hospital
Sofia, Bulgaria, 1407
3
Military Medical Academy Multiprofile Hospital for Active Treatment - Sofia
Sofia, Bulgaria, 1606
4
University of Hong Kong
Hong Kong, Hong Kong