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

NCT03714152 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-01-27

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ABI-H2158

5 mg or 25 mg tablets

DRUG

Placebo for ABI-H2158

Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-13
Primary Completion
2020-11-23
Completion
2021-01-07
FDA Drug
Yes

Countries

  • United States
  • Australia
  • China
  • Hong Kong
  • New Zealand
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03714152 on ClinicalTrials.gov