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

NCT07652697 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

ABX-002

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

Sponsors & Collaborators

  • Autobahn Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2025-02-17
Completion
2025-02-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07652697 on ClinicalTrials.gov