A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
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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. |
ClinicalTrials.gov Identifier: NCT03714152 |
Recruitment Status :
Completed
First Posted : October 22, 2018
Last Update Posted : January 27, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Hepatitis B | Drug: ABI-H2158 Drug: Placebo for ABI-H2158 | Phase 1 |
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 |

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
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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
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Drug: Placebo for ABI-H2158
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets |
- 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 ]

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.
Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Healthy volunteers:
- 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
- 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:
- Male or female ≥ 18 and ≤ 65 years of age.
-
In good general health except for chronic HBV infection, documented by:
- Clinical history, physical exam and routine laboratory measurements without major or clinically significant findings
- Serologic profile consistent with chronic HBV infection • HBeAg-positive at Screening with HBV viral load ≥ 2× 105 IU/mL
- Liver evaluation demonstrating the absence of bridging fibrosis or cirrhosis
Key Exclusion Criteria:
- History or evidence of decompensated liver disease at any time prior to Screening
- History or presence of any other clinically significant current medical conditions requiring ongoing pharmacological treatment.
- 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).
- Previous treatment with a commercially approved HBV therapy within the last 6 months

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 ClinicalTrials.gov identifier (NCT number): NCT03714152
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 |
Responsible Party: | Assembly Biosciences |
ClinicalTrials.gov 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 |
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 |
CHB HBV hepatitis B HBeAg positive |
Hepatitis A Hepatitis B Hepatitis B, Chronic Hepatitis Hepatitis, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Hepadnaviridae Infections DNA Virus Infections |