NCT07652697CompletedPhase 1
A Phase 1, Open-Label, Randomized, Single Dose Three-Way Crossover Study to Evaluate the Bioequivalence of, and the Effect of Food on, ABX-002 in Healthy Adult Participants
Autobahn Therapeutics, Inc.1 site in 1 country18 target enrollmentStarted: January 2, 2025Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Autobahn Therapeutics, Inc.
- Enrollment
- 18
- Locations
- 1
Study Overview
Brief Summary
The goal of this study is to assess the bioequivalence (BE) between the liquid formulation and the new solid formulation of ABX-002 under fasting conditions and to evaluate the effect of food on the pharmacokinetics (PK) of the new solid formulation of ABX-002.This study design is consistent with FDA guidelines for the assessment of BE.
This was an open label, randomized, single dose, three-way crossover BE and food-effect study. Therefore, the total number of participants in this study was 18.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
- •BMI ≥ 18.0 and ≤ 32.0 kg/m2 and minimum weight of 50 kg at the screening visit
- •Medically healthy, as deemed by the PI or designee, with no clinically significant medical history, or clinically significant abnormalities in physical examination, clinical laboratory profiles, and vital signs
- •Capable of providing written informed consent, able to understand the nature of the trial and, in the opinion of the PI or designee, able to follow all protocol requirements including the schedule of assessments
Exclusion Criteria
- •Mentally or legally incapacitated or had significant emotional problems at the time of the screening visit or expected during the conduct of the study
- •History of any illness that, in the opinion of the PI or designee, might have confounded the results of the study or posed an additional risk to the participant
- •History or presence of alcohol or drug abuse within the past 2 years prior to the first dosing
- •History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds
- •History of thyroid disease
- •History or presence of Clinically significant cataract, glaucoma, severe ocular trauma, inflammatory eye disease, or prior ophthalmic surgical procedures or laser surgery in either eye.
- •Clinically significant abnormalities on 12-lead ECG at the screening visit
- •Positive urine drug or alcohol results at the screening visit or check-in
Investigators
Study Sites (1)
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