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ABI-H3733

Phase 1

Chronic Hepatitis B | Small molecule | Infectious Disease |Assembly Biosciences, Inc.|Last Updated: Jun 29, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

ABI-H3733 · 1 trial · 1 indication

Phase 1 1
NCT05414981A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus InfectionChronic Hepatitis B
COMPLETED31 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
Chronic Hepatitis BUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABI-H3733ACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ABI-H3733DRUG25 mg or 100 mg tablets for oral administration
PlaceboDRUG25 mg or 100 mg tablets for oral administration
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

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...

Countries:BulgariaHong KongMoldovaNew ZealandRomaniaSingapore
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Frequently asked questions about ABI-H3733

What is ABI-H3733 used for?

ABI-H3733 is an investigational small molecule being developed for the treatment of chronic Hepatitis B. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes ABI-H3733?

ABI-H3733 is being developed by Assembly Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol ASMB.

What phase is ABI-H3733 in?

ABI-H3733 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational, meaning it is not yet approved for commercial use.

What clinical trials is ABI-H3733 in?

ABI-H3733 has one completed Phase 1 clinical trial, registered as NCT05414981. This study assessed the safety, pharmacokinetics, and antiviral activity of ABI-H3733 in subjects with chronic Hepatitis B virus infection.

What does ABI-H3733 target?

ABI-H3733 is a small molecule designed to treat chronic Hepatitis B. The specific molecular target has not been disclosed in the available information.