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CompletedNCT03714152Updated Jan 27, 2021

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

A Phase 1 interventional study of ABI-H2158 and Placebo for ABI-H2158 in Chronic Hepatitis B, sponsored by Assembly Biosciences. Completed at 14 sites in 7 countries. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Assembly Biosciences · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Nov 2020, 5 years 10 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

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.

02

Conditions studied

  • Chronic Hepatitis B

Keywords

  • CHB
  • HBV
  • hepatitis B
  • HBeAg positive
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 80 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Assembly Biosciences is the lead sponsor of 23 studies on the registry; 2 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 7 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Healthy volunteers:

  1. Male or female between 18 and 55 years old with a BMI of 18-34 kg/m2 with a minimum body weight of 45 kg
  2. Must be in good health and not have any health condition which could interfere with the absorption, distribution or elimination of study drug, or with the clinical and laboratory assessments in this study

Chronic HBV patients:

Key Inclusion Criteria:

  1. Male or female ≥ 18 and ≤ 65 years of age.
  2. In good general health except for chronic HBV infection, documented by:

    1. Clinical history, physical exam and routine laboratory measurements without major or clinically significant findings
    2. Serologic profile consistent with chronic HBV infection • HBeAg-positive at Screening with HBV viral load ≥ 2× 105 IU/mL
  3. Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis

Key Exclusion Criteria:

  1. History or evidence of decompensated liver disease at any time prior to Screening
  2. History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment.
  3. Previous treatment with any investigational HBV antiviral treatments within the last 6 months, or previous treatment at any time with an investigational HBV antiviral treatment of the same class (core protein targeted therapies).
  4. Previous treatment with a commercially approved HBV therapy within the last 6 months
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    ABI-H2158

    ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days

    Drug: ABI-H2158

  • Placebo comparator
    Matching Placebo for ABI-H2158

    Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days

    Drug: Placebo for ABI-H2158

Interventions

  • DrugABI-H2158

    5 mg or 25 mg tablets

  • DrugPlacebo for ABI-H2158

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

06

What researchers measure

Primary outcomes

  1. Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.

    Time frame: Up to 28 days

07

Study locations

14 sites
  • Southern California Research Center
    Coronado, California 92118, United States
  • Research and Education
    San Diego, California 92115, United States
  • Quest Clinical Research
    San Francisco, California 94115, United States
  • Infectious Disease Care
    Hillsborough, New Jersey 08844, United States
  • Monash University
    Clayton, Victoria, Australia
  • The Alfred Hospital
    Melbourne, Victoria, Australia
  • Linear Clinical Research
    Nedlands, Western Australia, Australia
  • First Hospital of Jilin University
    Jilin, Changchun 130000, China
  • University of Hong Kong, Queen Mary Hospital
    Hong Kong, Hong Kong
  • Hallym University
    Chuncheon, Korea, Republic of
  • Asan Medical Center
    Seoul, Korea, Republic of
  • Severance Hospital, Yonsei University
    Seoul, Korea, Republic of
  • Auckland Clinical Studies
    Auckland, New Zealand
  • King's College London
    London, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03714152
Lead sponsor
Assembly Biosciences
Responsible party
Sponsor
First posted
Oct 22, 2018
Start date
Nov 13, 2018
Primary completion
Nov 23, 2020
Completion
Jan 7, 2021
Last update
Jan 27, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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