Clinical trial NCT05569941: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis B
Keywords: ABI-4334
PK
Healthy Subjects
Lead sponsor: Assembly Biosciences
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results
timeFrame: Up to Day 14
Secondary outcomes:
measure: SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334
timeFrame: before and at pre-specified time points up to 144 hours after dosing
measure: SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334
timeFrame: before and at pre-specified time points up to 144 hours after dosing
measure: SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334
timeFrame: before and at pre-specified time points up to 144 hours after dosing
measure: SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334
timeFrame: before and at pre-specified time points up to 144 hours after dosing
measure: SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334
timeFrame: before and at pre-specified time points up to 144 hours after dosing
measure: SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334
timeFrame: before and at pre-specified time points up to 144 hours after dosing
measure: SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334
timeFrame: before and at pre-specified time points up to 144 hours after dosing
measure: SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334
timeFrame: before and at pre-specified time points up to 144 hours after dosing
measure: MAD Cohorts 1-2: AUC of ABI-4334
timeFrame: 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
measure: MAD Cohorts 1-2: Cmax of ABI-4334
timeFrame: 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
measure: MAD Cohorts 1-2: Tmax of ABI-4334
timeFrame: 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
measure: MAD Cohorts 1-2: t 1/2 of ABI-4334
timeFrame: 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
measure: MAD Cohorts 1-2: CL/F of ABI-4334
timeFrame: 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
measure: MAD Cohorts 1-2: Vz/F of ABI-4334
timeFrame: 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
Other outcomes:
Locations:
city: Grafton
country: New Zealand
facility: New Zealand Clinical Research
state: Auckland
Study officials:
affiliation: New Zealand Clinical Research
name: Edward Gane
role: PRINCIPAL_INVESTIGATOR
References: