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

• ClinicalTrials.gov Identifier: NCT03714152
• Recruitment Status: Completed
• First Posted: October 22, 2018
• Last Update Posted: January 27, 2021
• Sponsor: Assembly Biosciences
• Information provided by (Responsible Party): Assembly Biosciences

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

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

More Information

• Responsible Party: Assembly Biosciences
• ClinicalTrials.gov Identifier: NCT03714152
• Other Study ID Numbers: ABI-H2158-101
• First Posted: October 22, 2018
• 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

Keywords provided by Assembly Biosciences:

CHB; HBV; hepatitis B; HBeAg positive

Additional relevant MeSH terms:

Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic; Liver Diseases; Digestive System Diseases; Hepatitis, Viral, Human; Virus Diseases; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepadnaviridae Infections; DNA Virus Infections