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

NCT07652697 | Completed Phase 1 FDA Drug

• 1 other identifier: ABX-002-1903
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healthy Volunteers; Bioequivalence; Elunetirom

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

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

  8 weeks

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

  8 weeks

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

  8 weeks

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

  8 weeks

Study Arms (6)

Sequence ABC

EXPERIMENTAL

Sequence ABC

Drug: ABX-002

Sequence BCA

EXPERIMENTAL

Sequence BCA

Drug: ABX-002

Sequence CAB

EXPERIMENTAL

Sequence CAB

Drug: ABX-002

Sequence ACB

EXPERIMENTAL

Sequence ACB

Drug: ABX-002

Sequence BAC

EXPERIMENTAL

Sequence BAC

Drug: ABX-002

Sequence CBA

EXPERIMENTAL

Sequence CBA

Drug: ABX-002

Interventions

ABX-002 DRUG

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

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Autobahn Therapeutics, Inc.: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants received each treatment on one occasion. The treatment sequences participants were randomized to included: ABC, BCA, CAB, ACB, BAC, and CBA.

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 17, 2026
• Study Start: January 2, 2025
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

US (1)