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

Chronic Hepatitis B Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05569941
• Other study ID #: ABI-4334-101
• Status: Completed
• Phase: Phase 1
• Start date: November 11, 2022
• Est. completion date: April 12, 2023

Study information

• Verified date: September 2023
• Source: Assembly Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 12, 2023
• Est. primary completion date: April 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• ABI-4334 Tablet
ABI-4334 Tablet
• ABI-4334 Placebo
Placebo to ABI-4334 Tablet

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Grafton	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	Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results		Up to Day 14
Secondary	SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334		before and at pre-specified time points up to 144 hours after dosing
Secondary	SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334		before and at pre-specified time points up to 144 hours after dosing
Secondary	SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334		before and at pre-specified time points up to 144 hours after dosing
Secondary	SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334		before and at pre-specified time points up to 144 hours after dosing
Secondary	SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334		before and at pre-specified time points up to 144 hours after dosing
Secondary	SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334		before and at pre-specified time points up to 144 hours after dosing
Secondary	SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334		before and at pre-specified time points up to 144 hours after dosing
Secondary	SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334		before and at pre-specified time points up to 144 hours after dosing
Secondary	MAD Cohorts 1-2: AUC of ABI-4334		before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary	MAD Cohorts 1-2: Cmax of ABI-4334		before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary	MAD Cohorts 1-2: Tmax of ABI-4334		before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary	MAD Cohorts 1-2: t 1/2 of ABI-4334		before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary	MAD Cohorts 1-2: CL/F of ABI-4334		before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8
Secondary	MAD Cohorts 1-2: Vz/F of ABI-4334		before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8