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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05569941




Registration number
NCT05569941
Ethics application status
Date submitted
3/10/2022
Date registered
6/10/2022
Date last updated
13/09/2023

Titles & IDs
Public title
A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
Scientific title
A Phase 1, Blinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics of Single and Multiple Ascending Doses of ABI-4334 in Healthy Subjects
Secondary ID [1] 0 0
ABI-4334-101
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-4334 Tablet
Treatment: Drugs - ABI-4334 Placebo

Experimental: Part A: SAD Cohorts 1-5 ABI-4334 Tablet - A single dose of ABI-4334 will be administered on Day 1 in dose-escalation cohorts with a starting dose of 30 mg. The doses for subsequent cohorts will be determined by evaluation of safety and PK data from previous cohorts.

Placebo Comparator: Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet - A single dose of placebo matching ABI-4334 will be administered on Day 1.

Experimental: Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet - A single dose of ABI-4334 will be administered after a high-fat meal on Day 1 in cohort 6. A single dose of ABI-4334 will be administered on two separate occasions, once fasted and once after a high-fat meal in cohort 7. The dose administered will be determined after evaluation of cumulative safety and PK data from cohorts 1-5.

Placebo Comparator: Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet - A single dose of placebo matching ABI-4334 will be administered on Day 1 after a high-fat meal on Day 1 in cohort 6.

Experimental: Part B: MAD Cohorts 1-2 ABI-4334 Tablet - Once-daily doses of ABI-4334 will be administered from Day 1 to Day 8. Cohort B1 will receive a dose determined from evaluation of the data from the SAD cohorts. The doses for the subsequent cohort will be determined by evaluation of safety and PK data from previous cohorts.

Placebo Comparator: Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet - Once-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8.


Treatment: Drugs: ABI-4334 Tablet
ABI-4334 Tablet

Treatment: Drugs: ABI-4334 Placebo
Placebo to ABI-4334 Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
Timepoint [1] 0 0
Up to Day 14
Secondary outcome [1] 0 0
SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334
Timepoint [1] 0 0
before and at pre-specified time points up to 144 hours after dosing
Secondary outcome [2] 0 0
SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334
Timepoint [2] 0 0
before and at pre-specified time points up to 144 hours after dosing
Secondary outcome [3] 0 0
SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334
Timepoint [3] 0 0
before and at pre-specified time points up to 144 hours after dosing
Secondary outcome [4] 0 0
SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334
Timepoint [4] 0 0
before and at pre-specified time points up to 144 hours after dosing
Secondary outcome [5] 0 0
SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334
Timepoint [5] 0 0
before and at pre-specified time points up to 144 hours after dosing
Secondary outcome [6] 0 0
SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334
Timepoint [6] 0 0
before and at pre-specified time points up to 144 hours after dosing
Secondary outcome [7] 0 0
SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334
Timepoint [7] 0 0
before and at pre-specified time points up to 144 hours after dosing
Secondary outcome [8] 0 0
SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334
Timepoint [8] 0 0
before and at pre-specified time points up to 144 hours after dosing
Secondary outcome [9] 0 0
MAD Cohorts 1-2: AUC of ABI-4334
Timepoint [9] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary outcome [10] 0 0
MAD Cohorts 1-2: Cmax of ABI-4334
Timepoint [10] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary outcome [11] 0 0
MAD Cohorts 1-2: Tmax of ABI-4334
Timepoint [11] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary outcome [12] 0 0
MAD Cohorts 1-2: t 1/2 of ABI-4334
Timepoint [12] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary outcome [13] 0 0
MAD Cohorts 1-2: CL/F of ABI-4334
Timepoint [13] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary outcome [14] 0 0
MAD Cohorts 1-2: Vz/F of ABI-4334
Timepoint [14] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8

Eligibility
Key inclusion criteria
- Body mass index (BMI) between 18.0 and 30.0 kg/m2

- In good health (as determined by the Investigator) based on medical history, physical
examination, ECG, and clinical laboratory results.

- Female subjects must be non-pregnant and have a negative serum pregnancy test at
Screening and a negative urine pregnancy test at Day 1

- Agreement to comply with protocol-specified contraceptive requirements
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Positive results for any of the following serology tests, HBsAg, hepatitis B core
antibody (HBcAb IgM), hepatitis C virus antibody (HCV Ab), or HIV-1 or -2 antibody

- History of any illness that, in the opinion of the Investigator, might confound the
results of the study, pose an additional risk in administering study drug to the
subject, or a condition known to interfere with the absorption/
distribution/elimination of drugs.

- History of any significant drug-related allergic reactions such as anaphylaxis,
Stevens-Johnson syndrome, urticaria, or multiple drug allergies

- History of persistent alcohol abuse or illicit drug abuse within 3 years prior to
Screening

- Has participated in a clinical study involving administration of either an
investigational or a marketed drug within 2 months before Screening

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/04/2023
Sample size
Target
Accrual to date
Final
54
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD)
of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy
subjects. Effect of food will also be evaluated in Part A.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05569941
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edward Gane
Address 0 0
New Zealand Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries