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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03714152
• Other study ID #: ABI-H2158-101
• Status: Completed
• Phase: Phase 1
• Start date: November 13, 2018
• Est. completion date: January 7, 2021

Study information

• Verified date: January 2021
• Source: Assembly Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 7, 2021
• Est. primary completion date: November 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Assembly Biosciences

Countries where clinical trial is conducted

United States,  Australia,  China,  Hong Kong,  Korea, Republic of,  New Zealand,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.		Up to 28 days