Who is sponsoring NCT04083716?

NCT04083716 is sponsored by Assembly Biosciences.

What drugs are being tested in NCT04083716?

Interventions in NCT04083716: ABI-H2158 Reference Formulation, ABI-H2158 Test Formulation.

What condition does NCT04083716 study?

NCT04083716 studies Chronic Hepatitis B.

Is NCT04083716 still recruiting?

NCT04083716 is currently completed. Last updated 29 November 2019.

Last reviewed 2019-11-29 · How we verify

NCT04083716

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 Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults

Completed Phase 1 Last updated 29 November 2019

What this trial tests

Phase 1 trial testing ABI-H2158 Reference Formulation in Chronic Hepatitis B in 15 participants. Completed in 7 October 2019.

Timeline

6 September 2019

Primary endpoint
5 October 2019

7 October 2019

Quick facts

Lead sponsor	Assembly Biosciences
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	6 September 2019
Primary completion	5 October 2019
Estimated completion	7 October 2019
Sites	1 location across United States

Drugs / interventions tested

ABI-H2158 Reference Formulation — full drug profile →
ABI-H2158 Test Formulation — full drug profile →

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 the relative bioavailability of ABI-H2158 tablets (Test Formulation) compared to ABI-H2158 tablets (Reference Formulation). The effect of food on the pharmacokinetics of the Test Formulation will also be evaluated under fed and fasting conditions.

Publications & conference data

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

Targeting the multifunctional HBV core protein as a potential cure for chronic hepatitis B.
Viswanathan U, Mani N, Hu Z, Ban H, et al · · 2020 · cited 80× · PMID 32818519 · DOI 10.1016/j.antiviral.2020.104917
New Approaches to the Treatment of Chronic Hepatitis B.
Alexopoulou A, Vasilieva L, Karayiannis P. · · 2020 · cited 50× · PMID 33019573 · DOI 10.3390/jcm9103187

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 NCT04083716 (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 November 2019

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/NCT04083716.

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