Chronic Hepatitis B
Conditions
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.
Interventions
DRUGABI-H3733 Liquid Oral Dosage Form
ABI-H3733 liquid oral dosage form
DRUGABI-H3733 Solid Oral Dosage Form
ABI-H3733 solid oral dosage form
DRUGPlacebo to ABI-H3733 Liquid Oral Dosage Form
Placebo to ABI-H3733 liquid oral dosage form
DRUGPlacebo to ABI-H3733 Solid Oral Dosage Form
Placebo to ABI-H3733 solid oral dosage form
Sponsors
Assembly Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* No clinically significant abnormal findings on physical exam, medical history, or clinical laboratory results at screening.
Exclusion criteria
* Positive test results for human immunodeficiency virus (HIV) or hepatitis B or C. * History of or current persistent drug or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Adverse Events | Up to Day 10 |
| Number of Participants with One or More Related Adverse Events | Up to Day 10 |
| Number of Participants with One or More Severe (Grade ≥3) Adverse Events | Up to Day 10 |
Secondary
| Measure | Time frame |
|---|---|
| SAD Cohorts 1-7: Apparent Terminal Elimination Half-life (t1/2) of ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
| SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
| SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
| MAD Cohorts 8-10: AUC of ABI-H3733 | 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 |
| MAD Cohorts 8-10: Cmax Over the Dosing Interval of ABI-H3733 | 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 |
| SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
| MAD Cohorts 8-10: t1/2 of ABI-H3733 | 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 |
| Single Dose Cohorts 11-12: AUC of ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
| Single Dose Cohorts 11-12: Cmax of ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
| Single Dose Cohorts 11-12: Tmax of ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
| Single Dose Cohorts 11-12: t1/2 of ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
| MAD Cohorts 8-10: Tmax of ABI-H3733 | 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 |
| SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
| SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733 | before and at pre-specified time points up to 120 hours after dosing |
Countries
New Zealand
Outcome results
None listed