NCT05569941 is a Phase 1 clinical trial of ABI-4334 Tablet in Chronic Hepatitis B, sponsored by Assembly Biosciences.

Who is sponsoring NCT05569941?

NCT05569941 is sponsored by Assembly Biosciences.

What drugs are being tested in NCT05569941?

Interventions in NCT05569941: ABI-4334 Tablet, ABI-4334 Placebo.

What condition does NCT05569941 study?

NCT05569941 studies Chronic Hepatitis B.

Is NCT05569941 still recruiting?

NCT05569941 is currently completed. Last updated 13 September 2023.

Last reviewed 2023-09-13 · How we verify

NCT05569941

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

A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects

Completed Phase 1 Last updated 13 September 2023

What this trial tests

Phase 1 trial testing ABI-4334 Tablet in Chronic Hepatitis B in 54 participants. Completed in 12 April 2023.

Timeline

11 November 2022

Primary endpoint
12 April 2023

12 April 2023

Quick facts

Lead sponsor	Assembly Biosciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	54
Start date	11 November 2022
Primary completion	12 April 2023
Estimated completion	12 April 2023
Sites	1 location across New Zealand

Drugs / interventions tested

ABI-4334 Tablet
ABI-4334 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 study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.

Publications & conference data

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

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
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
Current status and challenges of therapeutic targets, novel drugs and delivery systems for hepatitis B: how far to our goal?
Liao Y, Lv F, Zhou M, Shen J, et al · · 2025 · PMID 41613597 · DOI 10.3389/fcimb.2025.1692924

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
NCT05414981 — A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B · 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 NCT05569941 (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: 13 September 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/NCT05569941.

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