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

Primary Purpose

Chronic Hepatitis B

Status

Completed

Phase

Phase 1

Locations

New Zealand

Study Type

Interventional

Intervention

ABI-4334 Tablet

ABI-4334 Placebo

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring ABI-4334, PK, Healthy Subjects

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

New Zealand Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

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

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

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

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

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

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

Arm 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.

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

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.

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.

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.

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

Outcomes

Primary Outcome Measures

Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results

Secondary Outcome Measures

SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334

SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334

SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334

SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334

SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334

SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334

SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334

SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334

MAD Cohorts 1-2: AUC of ABI-4334

MAD Cohorts 1-2: Cmax of ABI-4334

MAD Cohorts 1-2: Tmax of ABI-4334

MAD Cohorts 1-2: t 1/2 of ABI-4334

MAD Cohorts 1-2: CL/F of ABI-4334

MAD Cohorts 1-2: Vz/F of ABI-4334

Full Information

NCT ID

NCT05569941

First Posted

October 3, 2022

Last Updated

September 8, 2023

Sponsor

Assembly Biosciences

1. Study Identification

Unique Protocol Identification Number

NCT05569941

Brief Title

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

Official Title

A Phase 1, Blinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics of Single and Multiple Ascending Doses of ABI-4334 in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

November 11, 2022 (Actual)

Primary Completion Date

April 12, 2023 (Actual)

Study Completion Date

April 12, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assembly Biosciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

Keywords

ABI-4334, PK, Healthy Subjects

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Placebo Comparator

Arm 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.

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ABI-4334 Tablet

Intervention Description

ABI-4334 Tablet

Intervention Type

Drug

Intervention Name(s)

ABI-4334 Placebo

Intervention Description

Placebo to ABI-4334 Tablet

Primary Outcome Measure Information:

Title

Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results

Time Frame

Up to Day 14

Secondary Outcome Measure Information:

Title

SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334

Time Frame