A Phase 1a, Blinded, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Single- and Multiple-Ascending Doses of ABI-6250 in Healthy Subjects
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Assembly Biosciences
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results
Overview
Brief Summary
This study is designed to assess safety, tolerability, and pharmacokinetics of single ascending doses (SAD) and multiple-ascending doses (MAD) of ABI-6250 in healthy participants. Effect of food will also be evaluated in Part A.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Participant has a body mass index (BMI) between ≥18.0 and \<32.0 kg/m2 and is in good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
- •Female participants must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day-1 or Day 1 (predose).
- •Participants must agree to comply with protocol-specified contraceptive requirements.
Exclusion Criteria
- •Current infection of human immunodeficiency virus (HIV), hepatitis B virus, (HBV), hepatitis C virus (HCV) or acute hepatitis A virus (HAV).
- •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 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 30 days or 5 half-lives before screening, whatever is longer.
Arms & Interventions
Part A: SAD Food Effect Cohort 6 or 7: ABI-6250
Intervention: ABI-6250 (Drug)
Part B: MAD Cohorts 1-4, Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Proportion of subjects with AEs, premature treatment discontinuation due to AEs and abnormal laboratory results
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Area Under the Plasma Concentration Time Curve (AUC) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Maximum Observed Plasma Concentration (Cmax) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Time to Cmax (Tmax) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Terminal Elimination Half Life (t 1/2) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Systemic Clearance (CL/F) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Apparent Volume of Distribution (Vz/F) of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Dose normalized AUCs and Cmax of ABI-6250
Time Frame: From enrollment to 10 days after the last dose, at pre-specified timepoints
Secondary Outcomes
- Comparison of plasma AUC between fasted and fed treatments(From enrollment to 10 days after the last dose, at pre-specified timepoints)
- Comparison of AUC between fasted and fed treatments(From enrollment to 10 days after the last dose, at pre-specified timepoints)