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A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

NCT02908191 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2019-04-04

No results posted yet for this study

Summary

This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.

Conditions

Interventions

DRUG

ABI-H0731

DRUG

Placebo for ABI-H0731

DRUG

Entecavir

Used to treat adults with chronic hepatitis B virus

DRUG

Tenofovir disoproxil fumarate

Used to treat adults with chronic hepatitis B virus

DRUG

Pegasys

Used to treat adults with chronic hepatitis B virus who show signs of liver damage

DRUG

Nucleos(t)ide

Used to treat adults with chronic hepatitis B virus

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-03-31
Completion
2018-06-12

Countries

  • New Zealand

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 NCT02908191 on ClinicalTrials.gov