A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects

Assembly Biosciences

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: ABI-4334 Placebo; Drug: ABI-4334 Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT05569941

ABI-4334-101

Details and patient eligibility

About

This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.

Enrollment: 54 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body mass index (BMI) between 18.0 and 30.0 kg/m2
• In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
• Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1
• Agreement to comply with protocol-specified contraceptive requirements

Exclusion criteria

• Positive results for any of the following serology tests, HBsAg, hepatitis B core antibody (HBcAb IgM), hepatitis C virus antibody (HCV Ab), or HIV-1 or -2 antibody
• History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or a condition known to interfere with the absorption/ distribution/elimination of drugs.
• History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, urticaria, or multiple drug allergies
• History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
• Has participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months before Screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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54 participants in 6 patient groups, including a placebo group

Part A: SAD Cohorts 1-5 ABI-4334 Tablet

Experimental group

Description:

A single dose of ABI-4334 will be administered on Day 1 in dose-escalation cohorts with a starting dose of 30 mg. The doses for subsequent cohorts will be determined by evaluation of safety and PK data from previous cohorts.

Treatment:

Drug: ABI-4334 Tablet

Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet

Placebo Comparator group

Description:

A single dose of placebo matching ABI-4334 will be administered on Day 1.

Treatment:

Drug: ABI-4334 Placebo

Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet

Experimental group

Description:

A single dose of ABI-4334 will be administered after a high-fat meal on Day 1 in cohort 6. A single dose of ABI-4334 will be administered on two separate occasions, once fasted and once after a high-fat meal in cohort 7. The dose administered will be determined after evaluation of cumulative safety and PK data from cohorts 1-5.

Treatment:

Drug: ABI-4334 Tablet

Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet

Placebo Comparator group

Description:

A single dose of placebo matching ABI-4334 will be administered on Day 1 after a high-fat meal on Day 1 in cohort 6.

Treatment:

Drug: ABI-4334 Placebo

Part B: MAD Cohorts 1-2 ABI-4334 Tablet

Experimental group

Description:

Once-daily doses of ABI-4334 will be administered from Day 1 to Day 8. Cohort B1 will receive a dose determined from evaluation of the data from the SAD cohorts. The doses for the subsequent cohort will be determined by evaluation of safety and PK data from previous cohorts.

Treatment:

Drug: ABI-4334 Tablet

Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet

Placebo Comparator group

Description:

Once-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8.

Treatment:

Drug: ABI-4334 Placebo