NCT05414981 is a Phase 1 clinical trial of ABI-H3733 in Chronic Hepatitis B, sponsored by Assembly Biosciences.

Who is sponsoring NCT05414981?

NCT05414981 is sponsored by Assembly Biosciences.

What drugs are being tested in NCT05414981?

Interventions in NCT05414981: ABI-H3733, Placebo.

What condition does NCT05414981 study?

NCT05414981 studies Chronic Hepatitis B.

Is NCT05414981 still recruiting?

NCT05414981 is currently completed. Last updated 29 June 2023.

Last reviewed 2023-06-29 · How we verify

NCT05414981

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection

Completed Phase 1 Last updated 29 June 2023

What this trial tests

Phase 1 trial testing ABI-H3733 in Chronic Hepatitis B in 31 participants. Completed in 24 April 2023.

Timeline

7 August 2022

Primary endpoint
24 April 2023

24 April 2023

Quick facts

Lead sponsor	Assembly Biosciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	31
Start date	7 August 2022
Primary completion	24 April 2023
Estimated completion	24 April 2023
Sites	9 locations across Hong Kong, New Zealand, Moldova, Romania, Bulgaria, Singapore

Drugs / interventions tested

ABI-H3733 — full drug profile →
Placebo

Conditions studied

Chronic Hepatitis B — all drugs for Chronic Hepatitis B →

Sponsor

Assembly Biosciences — full company profile →

Who can join

Adults 18 to 65, any sex, with Chronic Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

The progress of molecules and strategies for the treatment of HBV infection.
Pan Y, Xia H, He Y, Zeng S, et al · · 2023 · cited 33× · PMID 37009498 · DOI 10.3389/fcimb.2023.1128807
The premise of capsid assembly modulators towards eliminating HBV persistence.
Bassit L, Amblard F, Patel D, Biteau N, et al · · 2023 · cited 19× · PMID 37477111 · DOI 10.1080/17460441.2023.2239701
Current trends and advances in antiviral therapy for chronic hepatitis B.
Li J, Liu S, Zang Q, Yang R, et al · · 2024 · cited 7× · PMID 38945693 · DOI 10.1097/cm9.0000000000003178
Therapeutic advances in HBV cure.
Hui RW, Mak LY, Seto WK, Yuen MF. · · 2024 · cited 3× · PMID 38623151 · DOI 10.1097/cld.0000000000000161
Navigating the Viral Hepatitis Drug Landscape: New Discoveries and Enduring Challenges. A Narrative Review.
Sun HM, Wang XY, Xu HQ, Gao YH. · · 2026 · PMID 41817955 · DOI 10.1007/s40121-026-01321-8

Verify or expand the search:

Other recruiting trials for Chronic Hepatitis B

Currently open trials in the same condition.

NCT07275918 — SA1211 Injection Phase 1 Study · Phase 1 · recruiting
NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
NCT07135349 — A Phase II Clinical Study of BW-20507 in Combination With PEG-IFNα for the Treatment of Hepatitis B · Phase 2 · active not recruiting
NCT07307586 — A Small Sample Prospective Clinical Study of Azvudine Tablets to Promote Clinical Cure in Patients With Chronic Hepatiti · Phase 3 · recruiting
NCT07246889 — Study of AHB-137 in Participants With Chronic Hepatitis B (CHB) Treated With Nucleos(t)Ide Analogues (NAs)(AUSHINE) · Phase 3 · active not recruiting

Other Assembly Biosciences trials

Trials by the same sponsor.

NCT06740474 — A Study to Assess the Safety, Tolerability and Pharmacokinetics of ABI-6250 in Healthy Participants · Phase 1 · completed
NCT06698575 — A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropos · Phase 1 · completed
NCT06384131 — A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B · Phase 1 · completed
NCT06385327 — A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-5366 in Healthy Participants and Participa · Phase 1 · completed
NCT05569941 — A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05414981 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assembly Biosciences
Last refreshed: 29 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05414981.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing