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

11. juni 2026 opdateret af: Autobahn Therapeutics, Inc.

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68502
        • Celerion

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Sequence ABC
Medicin: ABX-002
ABX-002 was supplied as a solution and solid dose form.
Eksperimentel: Sequence BCA
Medicin: ABX-002
ABX-002 was supplied as a solution and solid dose form.
Eksperimentel: Sequence CAB
Medicin: ABX-002
ABX-002 was supplied as a solution and solid dose form.
Eksperimentel: Sequence ACB
Medicin: ABX-002
ABX-002 was supplied as a solution and solid dose form.
Eksperimentel: Sequence BAC
Medicin: ABX-002
ABX-002 was supplied as a solution and solid dose form.
Eksperimentel: Sequence CBA
Medicin: ABX-002
ABX-002 was supplied as a solution and solid dose form.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the bioequivalence between ABX-002 liquid formulation and ABX-002 solid formulation in healthy adult participants.
Tidsramme: 8 weeks
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
Tidsramme: 8 weeks
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
Tidsramme: 8 weeks
Change in Peak Plasma Concentration for ABX-002 and LL-340001
8 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluate the effect of a high-fat meal on the PK of ABX-002 solid formulation in healthy adult participants
Tidsramme: 8 weeks
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
Tidsramme: 8 weeks
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
Tidsramme: 8 weeks
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.
Tidsramme: 8 weeks
Incidence and severity of treatment-emergent adverse events to ABX-002 will be measured
8 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Autobahn Therapeutics, Inc.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. januar 2025

Primær færdiggørelse (Faktiske)

17. februar 2025

Studieafslutning (Faktiske)

17. februar 2025

Datoer for studieregistrering

Først indsendt

29. maj 2026

Først indsendt, der opfyldte QC-kriterier

11. juni 2026

Først opslået (Faktiske)

17. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • ABX-002-1903

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med ABX-002

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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