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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/NCT04271592




Registration number
NCT04271592
Ethics application status
Date submitted
13/02/2020
Date registered
17/02/2020
Date last updated
27/01/2021

Titles & IDs
Public title
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
Scientific title
A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Escalation and Food Effect Study of ABI-H3733 in Healthy Subjects
Secondary ID [1] 0 0
U1111-1246-2965
Secondary ID [2] 0 0
ABI-H3733-101
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-H3733 Liquid Oral Dosage Form
Treatment: Drugs - ABI-H3733 Solid Oral Dosage Form
Treatment: Drugs - Placebo to ABI-H3733 Liquid Oral Dosage Form
Treatment: Drugs - Placebo to ABI-H3733 Solid Oral Dosage Form

Experimental: Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form - A single dose of ABI-H3733 liquid oral dosage form administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a =3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts.

Placebo Comparator: Part 1: SAD Cohorts 1-7 Placebo Liquid Form - A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered on Day 1. Cohort 1 will receive a 100-mg dose. Subsequent cohorts 2-7 will receive a =3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts.

Experimental: Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form - Once-daily doses of ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a =3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts.

Placebo Comparator: Part 1: MAD Cohorts 8-10 Placebo Liquid Form - Once-daily doses of placebo matching ABI-H3733 liquid oral dosage form will be administered from Day 1 to Day 5. Cohort 8 will receive a dose determined from evaluation of the data from the SAD cohorts. Subsequent cohorts 9 and 10 will receive a =3-fold increase in dose from the previous cohort; the dose will be determined by evaluation of safety and PK data from previous cohorts.

Experimental: Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form - A single dose of ABI-H3733 solid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1.

Placebo Comparator: Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form - A single dose of placebo matching ABI-H3733 liquid oral dosage form will be administered in a fasted state on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1.

Experimental: Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form - A single dose of ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1.

Placebo Comparator: Part 2: Single Dose Fed Cohort 12 Placebo Solid Form - A single dose of placebo matching ABI-H3733 solid oral dosage form will be administered after a high-fat meal on Day 1. The decision to proceed with Part 2 and the dose administered will be determined after evaluation of cumulative safety and PK data from Part 1.


Treatment: Drugs: ABI-H3733 Liquid Oral Dosage Form
ABI-H3733 liquid oral dosage form

Treatment: Drugs: ABI-H3733 Solid Oral Dosage Form
ABI-H3733 solid oral dosage form

Treatment: Drugs: Placebo to ABI-H3733 Liquid Oral Dosage Form
Placebo to ABI-H3733 liquid oral dosage form

Treatment: Drugs: Placebo to ABI-H3733 Solid Oral Dosage Form
Placebo to ABI-H3733 solid oral dosage form
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with One or More Adverse Events
Timepoint [1] 0 0
Up to Day 10
Primary outcome [2] 0 0
Number of Participants with One or More Related Adverse Events
Timepoint [2] 0 0
Up to Day 10
Primary outcome [3] 0 0
Number of Participants with One or More Severe (Grade =3) Adverse Events
Timepoint [3] 0 0
Up to Day 10
Secondary outcome [1] 0 0
SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-H3733
Timepoint [1] 0 0
before and at pre-specified time points up to 120 hours after dosing
Secondary outcome [2] 0 0
SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733
Timepoint [2] 0 0
before and at pre-specified time points up to 120 hours after dosing
Secondary outcome [3] 0 0
SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733
Timepoint [3] 0 0
before and at pre-specified time points up to 120 hours after dosing
Secondary outcome [4] 0 0
SAD Cohorts 1-7: Apparent Terminal Elimination Half-life (t1/2) of ABI-H3733
Timepoint [4] 0 0
before and at pre-specified time points up to 120 hours after dosing
Secondary outcome [5] 0 0
SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-H3733
Timepoint [5] 0 0
before and at pre-specified time points up to 120 hours after dosing
Secondary outcome [6] 0 0
SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-H3733
Timepoint [6] 0 0
before and at pre-specified time points up to 120 hours after dosing
Secondary outcome [7] 0 0
MAD Cohorts 8-10: AUC of ABI-H3733
Timepoint [7] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
Secondary outcome [8] 0 0
MAD Cohorts 8-10: Cmax Over the Dosing Interval of ABI-H3733
Timepoint [8] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
Secondary outcome [9] 0 0
MAD Cohorts 8-10: Tmax of ABI-H3733
Timepoint [9] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
Secondary outcome [10] 0 0
MAD Cohorts 8-10: t1/2 of ABI-H3733
Timepoint [10] 0 0
before and at pre-specified time points up to 24 hours after dosing on Day 1; before and up to 120 hours after dosing on Day 5
Secondary outcome [11] 0 0
Single Dose Cohorts 11-12: AUC of ABI-H3733
Timepoint [11] 0 0
before and at pre-specified time points up to 120 hours after dosing
Secondary outcome [12] 0 0
Single Dose Cohorts 11-12: Cmax of ABI-H3733
Timepoint [12] 0 0
before and at pre-specified time points up to 120 hours after dosing
Secondary outcome [13] 0 0
Single Dose Cohorts 11-12: Tmax of ABI-H3733
Timepoint [13] 0 0
before and at pre-specified time points up to 120 hours after dosing
Secondary outcome [14] 0 0
Single Dose Cohorts 11-12: t1/2 of ABI-H3733
Timepoint [14] 0 0
before and at pre-specified time points up to 120 hours after dosing

Eligibility
Key inclusion criteria
- No clinically significant abnormal findings on physical exam, medical history, or
clinical laboratory results at screening.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C.

- History of or current persistent drug or alcohol abuse.

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
Other
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
17/05/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/01/2021
Sample size
Target
Accrual to date
Final
120
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, pharmacokinetics (PK), formulation
(liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1
includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending
dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation.
Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under
fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2
of the study to explore additional dose levels, solid oral dosage formulations, or for cohort
expansion.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04271592
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Katia Alves, MD
Address 0 0
Assembly Biosciences
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