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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Autobahn Therapeutics, Inc.
Study ID
NCT07652697
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
19 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 2, 2025
Status verified
Jun 2026
Primary completion
Feb 17, 2025
Completion
Feb 17, 2025

Study Design

Enrollment
18 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Sequence ABC
    Sequence ABC
  • Experimental: Sequence BCA
    Sequence BCA
  • Experimental: Sequence CAB
    Sequence CAB
  • Experimental: Sequence ACB
    Sequence ACB
  • Experimental: Sequence BAC
    Sequence BAC
  • Experimental: Sequence CBA
    Sequence CBA

Primary Outcome Measure

Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation in healthy adult participants. [ Time Frame: 8 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
CelerionLincolnNebraska68502-

Find similar trials in Lincoln, NE

By research site
Celerion· Lincoln, NE

Related Studies