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

Sponsor

Assembly Biosciences (Industry)

Overall Status

Completed

CT.gov ID

NCT03714152

Collaborator

(none)

Enrollment

Locations

Arms

25.8

Actual Duration (Months)

5.7

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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

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 :

Nov 13, 2018

Actual Primary Completion Date :

Nov 23, 2020

Actual Study Completion Date :

Jan 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

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southern California Research Center	Coronado	California	United States	92118
2	Research and Education	San Diego	California	United States	92115
3	Quest Clinical Research	San Francisco	California	United States	94115
4	Infectious Disease Care	Hillsborough	New Jersey	United States	08844
5	Monash University	Clayton	Victoria	Australia
6	The Alfred Hospital	Melbourne	Victoria	Australia
7	Linear Clinical Research	Nedlands	Western Australia	Australia
8	First Hospital of Jilin University	Jilin	Changchun	China	130000
9	University of Hong Kong, Queen Mary Hospital	Hong Kong		Hong Kong
10	Hallym University	Chuncheon		Korea, Republic of
11	Asan Medical Center	Seoul		Korea, Republic of
12	Severance Hospital, Yonsei University	Seoul		Korea, Republic of
13	Auckland Clinical Studies	Auckland		New Zealand
14	King's College London	London		United Kingdom