A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults

Chronic Hepatitis B Clinical Trial

Official title:

A Phase 1, Randomized, Blinded, Placebo-Controlled, Single and Multiple Dose Escalation and Food Effect Study of ABI-H3733 in Healthy Subjects

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
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis B
• Hepatitis B, Chronic

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