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

Assembly Biosciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: ABI-H3733 Solid Oral Dosage Form; Drug: ABI-H3733 Liquid Oral Dosage Form; Drug: Placebo to ABI-H3733 Solid Oral Dosage Form; Drug: Placebo to ABI-H3733 Liquid Oral Dosage Form

Study type: Interventional

Funder types: Industry

Identifiers

NCT04271592

ABI-H3733-101

U1111-1246-2965 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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120 participants in 8 patient groups, including a placebo group

Part 1: SAD Cohorts 1-7 ABI-H3733 Liquid Form

Experimental group

Description:

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.

Treatment:

Drug: ABI-H3733 Liquid Oral Dosage Form

Part 1: SAD Cohorts 1-7 Placebo Liquid Form

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to ABI-H3733 Liquid Oral Dosage Form

Part 1: MAD Cohorts 8-10 ABI-H3733 Liquid Form

Experimental group

Description:

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.

Treatment:

Drug: ABI-H3733 Liquid Oral Dosage Form

Part 1: MAD Cohorts 8-10 Placebo Liquid Form

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to ABI-H3733 Liquid Oral Dosage Form

Part 2: Single Dose Fasted Cohort 11 ABI-H3733 Solid Form

Experimental group

Description:

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.

Treatment:

Drug: ABI-H3733 Solid Oral Dosage Form

Part 2: Single Dose Fasted Cohort 11 Placebo Solid Form

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo to ABI-H3733 Solid Oral Dosage Form

Part 2: Single Dose Fed Cohort 12 ABI-H3733 Solid Form

Experimental group

Description:

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.

Treatment:

Drug: ABI-H3733 Solid Oral Dosage Form

Part 2: Single Dose Fed Cohort 12 Placebo Solid Form

Placebo Comparator group

Description:

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:

Drug: Placebo to ABI-H3733 Solid Oral Dosage Form