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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: ABX-002

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence ABC	Drug: ABX-002; ABX-002 was supplied as a solution and solid dose form.
Experimental: Sequence BCA	Drug: ABX-002; ABX-002 was supplied as a solution and solid dose form.
Experimental: Sequence CAB	Drug: ABX-002; ABX-002 was supplied as a solution and solid dose form.
Experimental: Sequence ACB	Drug: ABX-002; ABX-002 was supplied as a solution and solid dose form.
Experimental: Sequence BAC	Drug: ABX-002; ABX-002 was supplied as a solution and solid dose form.
Experimental: Sequence CBA	Drug: ABX-002; ABX-002 was supplied as a solution and solid dose form.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation in healthy adult participants.	Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001	8 weeks
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation	Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001	8 weeks
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation	Change in Peak Plasma Concentration for ABX-002 and LL-340001	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants	Change in Change in Area Under the Curve from time zero to the last quantifiable concentration for ABX-002 and LL-340001	8 weeks
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants	Change in Area Under the Curve from time zero to infinity for ABX-002 and LL-340001	8 weeks
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants	Change in Peak Plasma Concentration for ABX-002 and LL-340001	8 weeks
Evaluate the safety and tolerability of 3 total doses of ABX-002 in healthy adult participants.	Incidence and severity of treatment-emergent adverse events to ABX-002 will be measured	8 weeks

Collaborators and Investigators

• Sponsor: Autobahn Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Actual): February 17, 2025
• Study Completion (Actual): February 17, 2025

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Bioequivalence; Healthy Volunteers; Elunetirom
• Other Study ID Numbers: ABX-002-1903

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No