Clinical trial NCT04271592: A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults
Official title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Escalation and Food Effect Study of ABI-H3733 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2020-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants with One or More Adverse Events
timeFrame: Up to Day 10
measure: Number of Participants with One or More Related Adverse Events
timeFrame: Up to Day 10
measure: Number of Participants with One or More Severe (Grade ≥3) Adverse Events
timeFrame: Up to Day 10
Secondary outcomes:
measure: SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
measure: SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
measure: SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
measure: SAD Cohorts 1-7: Apparent Terminal Elimination Half-life (t1/2) of ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
measure: SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
measure: SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
measure: MAD Cohorts 8-10: AUC of ABI-H3733
timeFrame: 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
measure: MAD Cohorts 8-10: Cmax Over the Dosing Interval of ABI-H3733
timeFrame: 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
measure: MAD Cohorts 8-10: Tmax of ABI-H3733
timeFrame: 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
measure: MAD Cohorts 8-10: t1/2 of ABI-H3733
timeFrame: 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
measure: Single Dose Cohorts 11-12: AUC of ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
measure: Single Dose Cohorts 11-12: Cmax of ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
measure: Single Dose Cohorts 11-12: Tmax of ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
measure: Single Dose Cohorts 11-12: t1/2 of ABI-H3733
timeFrame: before and at pre-specified time points up to 120 hours after dosing
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: Auckland Clinical Studies
Study officials:
affiliation: Assembly Biosciences
name: Katia Alves, MD
role: STUDY_DIRECTOR
References: