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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04271592
Other study ID # ABI-H3733-101
Secondary ID U1111-1246-2965
Status Completed
Phase Phase 1
First received
Last updated
Start date May 17, 2020
Est. completion date January 14, 2021

Study information

Verified date January 2021
Source Assembly Biosciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date January 14, 2021
Est. primary completion date November 3, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ABI-H3733 Liquid Oral Dosage Form
ABI-H3733 liquid oral dosage form
ABI-H3733 Solid Oral Dosage Form
ABI-H3733 solid oral dosage form
Placebo to ABI-H3733 Liquid Oral Dosage Form
Placebo to ABI-H3733 liquid oral dosage form
Placebo to ABI-H3733 Solid Oral Dosage Form
Placebo to ABI-H3733 solid oral dosage form

Locations

Country Name City State
New Zealand Auckland Clinical Studies Auckland

Sponsors (1)

Lead Sponsor Collaborator
Assembly Biosciences

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with One or More Adverse Events Up to Day 10
Primary Number of Participants with One or More Related Adverse Events Up to Day 10
Primary Number of Participants with One or More Severe (Grade =3) Adverse Events Up to Day 10
Secondary 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
Secondary SAD Cohorts 1-7: Maximum Plasma Concentration (Cmax) ABI-H3733 before and at pre-specified time points up to 120 hours after dosing
Secondary SAD Cohorts 1-7: Time of Cmax (Tmax) of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Single Dose Cohorts 11-12: AUC of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing
Secondary Single Dose Cohorts 11-12: Cmax of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing
Secondary Single Dose Cohorts 11-12: Tmax of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing
Secondary Single Dose Cohorts 11-12: t1/2 of ABI-H3733 before and at pre-specified time points up to 120 hours after dosing
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