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Completed Phase 1 Interventional Accepts healthy volunteers

A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B

ClinicalTrials.gov ID: NCT03714152

Public ClinicalTrials.gov record NCT03714152. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 7:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single and Multiple Doses of ABI-H2158 in Healthy Volunteers; and the Multiple-Ascending Dose Pharmacokinetics and Pharmacodynamics in Patients With Chronic Hepatitis B Infection

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.

Study identification

NCT ID
NCT03714152
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Assembly Biosciences
Industry
Enrollment
80 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 13, 2018 (Actual)
Primary completion
Nov 23, 2020 (Actual)
Completion
Jan 7, 2021 (Actual)
Last update posted
Jan 27, 2021

2018 – 2021

United States locations

U.S. sites
4
U.S. states
2
U.S. cities
4
Facility City State ZIP Site status
Southern California Research Center Coronado California 92118 —
Research and Education San Diego California 92115 —
Quest Clinical Research San Francisco California 94115 —
Infectious Disease Care Hillsborough New Jersey 08844 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 10 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03714152, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 27, 2021 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03714152 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →