A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
Phase 1
Completed
- Conditions
- Chronic Hepatitis B
- Interventions
- Drug: ABI-4334 TabletDrug: ABI-4334 Placebo
- Registration Number
- NCT05569941
- Lead Sponsor
- Assembly Biosciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: SAD Cohorts 1-5 ABI-4334 Tablet ABI-4334 Tablet 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. Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet ABI-4334 Placebo A single dose of placebo matching ABI-4334 will be administered on Day 1. Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet ABI-4334 Tablet 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. Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet ABI-4334 Placebo 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. Part B: MAD Cohorts 1-2 ABI-4334 Tablet ABI-4334 Tablet 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. Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet ABI-4334 Placebo Once-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8.
- Primary Outcome Measures
Name Time Method Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results Up to Day 14
- Secondary Outcome Measures
Name Time Method 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 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 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 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 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 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 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 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 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 SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334 before and at pre-specified time points up to 144 hours after dosing 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 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 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 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
Trial Locations
- Locations (1)
New Zealand Clinical Research
🇳🇿Grafton, Auckland, New Zealand