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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03714152
Recruitment Status : Completed
First Posted : October 22, 2018
Last Update Posted : January 27, 2021
Information provided by (Responsible Party):
Assembly Biosciences

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: ABI-H2158 Drug: Placebo for ABI-H2158 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 13, 2018
Actual Primary Completion Date : November 23, 2020
Actual Study Completion Date : January 7, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
5 mg or 25 mg tablets

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

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03714152

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United States, California
Southern California Research Center
Coronado, California, United States, 92118
Research and Education
San Diego, California, United States, 92115
Quest Clinical Research
San Francisco, California, United States, 94115
United States, New Jersey
Infectious Disease Care
Hillsborough, New Jersey, United States, 08844
Australia, Victoria
Monash University
Clayton, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Australia, Western Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
China, Changchun
First Hospital of Jilin University
Jilin, Changchun, China, 130000
Hong Kong
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Korea, Republic of
Hallym University
Chuncheon, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Severance Hospital, Yonsei University
Seoul, Korea, Republic of
New Zealand
Auckland Clinical Studies
Auckland, New Zealand
United Kingdom
King's College London
London, United Kingdom
Sponsors and Collaborators
Assembly Biosciences
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Responsible Party: Assembly Biosciences Identifier: NCT03714152    
Other Study ID Numbers: ABI-H2158-101
First Posted: October 22, 2018    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Assembly Biosciences:
hepatitis B
HBeAg positive
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections