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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03714152




Registration number
NCT03714152
Ethics application status
Date submitted
17/10/2018
Date registered
22/10/2018
Date last updated
7/04/2020

Titles & IDs
Public title
A Study of ABI-H2158 in Healthy Volunteers and Patients With Chronic Hepatitis B
Scientific 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
Secondary ID [1] 0 0
ABI-H2158-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABI-H2158
Treatment: Drugs - Placebo for ABI-H2158

Experimental: ABI-H2158 - ABI-H2158 in varying doses of tablets by mouth without and with food for 1 day or 10 days

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


Treatment: Drugs: ABI-H2158
5 mg or 25 mg tablets

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Timepoint [1] 0 0
Up to 28 days

Eligibility
Key inclusion 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

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
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Monash University - Clayton
Recruitment hospital [2] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [3] 0 0
Linear Clinical Research - Nedlands
Recruitment postcode(s) [1] 0 0
- Clayton
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
New Jersey
Country [3] 0 0
China
State/province [3] 0 0
Changchun
Country [4] 0 0
Hong Kong
State/province [4] 0 0
Hong Kong
Country [5] 0 0
Korea, Republic of
State/province [5] 0 0
Chuncheon
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
United Kingdom
State/province [8] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Assembly Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03714152
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Assembly Biosciences
Address 0 0
Country 0 0
Phone 0 0
833-509-4583
Fax 0 0
Email 0 0
clinicaltrials@assemblybio.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03714152