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Completed

NCT Number: NCT07652697

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

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.

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABX-002

Drug

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

Primary outcomes

  1. Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation in healthy adult participants.

    Time frame: 8 weeks

    Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001

  2. Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation

    Time frame: 8 weeks

    Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001

  3. Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation

    Time frame: 8 weeks

    Change in Peak Plasma Concentration for ABX-002 and LL-340001

Secondary outcomes

  1. Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants

    Time frame: 8 weeks

    Change in Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001

  2. Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants

    Time frame: 8 weeks

    Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001

  3. Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants

    Time frame: 8 weeks

    Change in Peak Plasma Concentration for ABX-002 and LL-340001

  4. Evaluate the safety and tolerability of 3 total doses of ABX-002 in healthy adult participants.

    Time frame: 8 weeks

    Incidence and severity of treatment-emergent adverse events to ABX-002 will be measured

Sponsors and collaborators

Lead sponsor

Autobahn Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 17, 2026
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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