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COMPLETED
NCT07652697
PHASE1

ABX-002 Bioequivalence and Effect of Food Study in Healthy Adult Participants

Sponsor: Autobahn Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

19 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2025-01-02

Completion Date

2025-02-17

Last Updated

2026-06-17

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

ABX-002

ABX-002 was supplied as a solution and solid dose form.

Locations (1)

Celerion

Lincoln, Nebraska, United States