Back to resultsA Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABI-H2158
Placebo for ABI-H2158
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B focused on measuring CHB, HBV, hepatitis B, HBeAg positive
Eligibility Criteria
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
Sites / Locations
- Southern California Research Center
- Research and Education
- Quest Clinical Research
- Infectious Disease Care
- Monash University
- The Alfred Hospital
- Linear Clinical Research
- First Hospital of Jilin University
- University of Hong Kong, Queen Mary Hospital
- Hallym University
- Asan Medical Center
- Severance Hospital, Yonsei University
- Auckland Clinical Studies
- King's College London
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ABI-H2158
Matching Placebo for ABI-H2158
Arm Description
ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days
Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days
Outcomes
Primary Outcome Measures
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Secondary Outcome Measures
Full Information
NCT ID
NCT03714152
First Posted
October 17, 2018
Last Updated
January 26, 2021
Sponsor
Assembly Biosciences
1. Study Identification
Unique Protocol Identification Number
NCT03714152
Brief Title
A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
November 23, 2020 (Actual)
Study Completion Date
January 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assembly Biosciences
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
CHB, HBV, hepatitis B, HBeAg positive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABI-H2158
Arm Type
Experimental
Arm Description
ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days
Arm Title
Matching Placebo for ABI-H2158
Arm Type
Placebo Comparator
Arm Description
Matching Placebo in varying doses of tablets by mouth without and with food for 1 day or 10 days
Intervention Type
Drug
Intervention Name(s)
ABI-H2158
Intervention Description
5 mg or 25 mg tablets
Intervention Type
Drug
Intervention Name(s)
Placebo for ABI-H2158
Intervention Description
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Research and Education
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Infectious Disease Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Monash University
City
Clayton
State/Province
Victoria
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Linear Clinical Research
City
Nedlands
State/Province
Western Australia
Country
Australia
Facility Name
First Hospital of Jilin University
City
Jilin
State/Province
Changchun
ZIP/Postal Code
130000
Country
China
Facility Name
University of Hong Kong, Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Hallym University
City
Chuncheon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University
City
Seoul
Country
Korea, Republic of
Facility Name
Auckland Clinical Studies
City
Auckland
Country
New Zealand
Facility Name
King's College London
City
London
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
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