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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06384131




Registration number
NCT06384131
Ethics application status
Date submitted
22/04/2024
Date registered
25/04/2024
Date last updated
25/09/2024

Titles & IDs
Public title
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
Scientific title
A Randomized, Blinded, Placebo-Controlled Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects With Chronic Hepatitis B Virus Infection
Secondary ID [1] 0 0
2024-511051-18
Secondary ID [2] 0 0
ABI-4334-102
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-4334
Treatment: Drugs - Placebo

Active comparator: ABI-4334 -

Placebo comparator: Placebo -


Treatment: Drugs: ABI-4334
10 mg or 50 mg tablets for oral administration

Treatment: Drugs: Placebo
10 mg or 50 mg tablets for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety and tolerability of ABI-4334 in subjects with cHBV following 28-day multiple oral doses
Timepoint [1] 0 0
Through end of study, up to 56 days
Secondary outcome [1] 0 0
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Timepoint [1] 0 0
Through treatment period, up to 28 days
Secondary outcome [2] 0 0
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Timepoint [2] 0 0
Through treatment period, up to 28 days
Secondary outcome [3] 0 0
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Timepoint [3] 0 0
Through treatment period, up to 28 days
Secondary outcome [4] 0 0
To characterize the PK of ABI-4334 in plasma following 28-day multiple doses in subjects with cHBV
Timepoint [4] 0 0
Through treatment period, up to 28 days
Secondary outcome [5] 0 0
Elimination half-life (t1/2) of ABI-4334 in subjects with cHBV
Timepoint [5] 0 0
Through treatment period, up to 28 days
Secondary outcome [6] 0 0
Changes in HBV pregenomic ribonucleic acid (pgRNA) and additional markers of antiviral activity in subjects with cHBV
Timepoint [6] 0 0
Through treatment period, up to 28 days
Secondary outcome [7] 0 0
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Timepoint [7] 0 0
Through treatment period, up to 28 days
Secondary outcome [8] 0 0
Changes in HBV DNA in subjects with cHBV following 28-day multiple doses of ABI-4334
Timepoint [8] 0 0
Through treatment period, up to 28 days

Eligibility
Key inclusion criteria
1. Body mass index (BMI) = 18.0 and < 35.0 kg/m(2), where BMI = weight (kg)/(height [m])(2) with a minimum body weight of 45 kg
2. Chronic hepatitis B infection, defined as HBV infection for = 6 months documented
3. Treatment-naïve or off-antiviral therapy for = 24 weeks prior to Screening
4. Lack of bridging fibrosis or cirrhosis
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis D virus (HDV), acute hepatitis A virus (HAV), or acute hepatitis E virus (HEV)
2. History of liver transplant or evidence of advanced liver disease, cirrhosis, or hepatic decompensation
3. Clinically significant diseases or conditions
4. History of hepatocellular carcinoma

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 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
8/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
22/04/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Sofia
Country [2] 0 0
Moldova, Republic of
State/province [2] 0 0
Chisinau
Country [3] 0 0
New Zealand
State/province [3] 0 0
Auckland
Country [4] 0 0
Romania
State/province [4] 0 0
Bucharest
Country [5] 0 0
Romania
State/province [5] 0 0
Cluj-Napoca

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, blinded, placebo-controlled, dose-ranging Phase 1b study of the safety, PK, and antiviral activity of ABI-4334 in treatment-naïve or off-treatment chronic Hepatitis B virus (cHBV) subjects that are Hepatitis B e antigen (HBeAg) positive or negative. The study will enroll up to 5 sequential cohorts of 10 subjects each, for a total of up to 50 subjects, randomized 8:2 to receive ABI-4334 or placebo.
Trial website
https://clinicaltrials.gov/study/NCT06384131
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06384131