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Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma

1. september 2026 opdateret af: Aspeya, Inc.

A Phase 1 Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single-dose of ASY202 in Adults With Asthma

This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma.

Following screening, eligible participants will be enrolled and randomized to one of two treatment sequences. Participants will receive a single inhaled dose of ASY202 and a single inhaled dose of placebo, each administered once during separate study periods.

During each treatment period, subjects will stay in the clinical research unit for safety monitoring and PK assessments, including serial blood sampling, spirometry, vital signs, clinical laboratory tests, and ECGs. Each period will include post dose assessments for up to 24 hours.

Participants will return for their next treatment period after a washout interval to ensure complete clearance of study medication. All subjects will receive both treatments over the course of the study.

A follow-up visit will occur after the last dose to assess ongoing safety and tolerability.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

40

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Forenede Stater
    • Arizona
      • Glendale, Arizona, Forenede Stater, 85304
        • Aktiv, ikke rekrutterende
        • Sun City Clinical Research
    • California
      • Anaheim, California, Forenede Stater, 92801
        • Rekruttering
        • CenExel- Anaheim Clinical trials LLC
        • Kontakt:
        • Ledende efterforsker:
          • Amina Z. Haggag, Dr.
    • Texas
      • San Antonio, Texas, Forenede Stater, 78217
        • Trukket tilbage
        • Worldwide Clinical Trials- Early Phase Research Unit

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

Ingen

Beskrivelse

Inclusion Criteria:

  • Adults aged 18-55 years
  • Diagnosed asthma
  • Stable asthma treatment
  • Non smoker
  • BMI 18.5-35 kg/m²
  • Women of childbearing potential and men agree to use acceptable contraception

Exclusion Criteria:

  • Asthma exacerbation requiring systemic steroids, ER visit, or hospitalization within 3 months
  • Respiratory tract infection within 4 weeks prior to screening
  • Use of oral or IV corticosteroids
  • Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids)
  • Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry
  • Unstable asthma or unresolved safety concerns before dosing
  • Clinically significant cardiovascular disease or ECG abnormalities contraindicating DHE
  • Three or more risk factors for Coronary Artery Disease (CAD) (hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age)
  • Pregnancy, breastfeeding, or unwillingness to use required contraception

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: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ASY202, then placebo
ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device.
Kombinationsprodukt: ASY202
ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI).
Kombinationsprodukt: Placebo
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
Eksperimentel: Placebo, then ASY202
In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2.
Kombinationsprodukt: ASY202
ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI).
Kombinationsprodukt: Placebo
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.
Tidsramme: Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.
Percentage change from baseline in FEV1 over time measured by spirometry at predefined timepoints post-dose (5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours), following administration of investigational product.
Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Tidsramme: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Change from baseline in FVC at any of the post-dose time points.
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Tidsramme: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Change from baseline in FEV1/FVC ratio at any of the post-dose time points
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Tidsramme: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Change from baseline in FEF 25-75 at any of the post-dose time points
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma
Tidsramme: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Proportion of participants with ≥20%, ≥15%, ≥10% reduction in FEV1 from baseline at any of the post-dose time points.
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of a single dose of ASY202 2 mg compared with placebo in adults with asthma.
Tidsramme: Up to 24 hours post dose and safety follow up to seven days after last dose
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
Up to 24 hours post dose and safety follow up to seven days after last dose
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Tidsramme: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
AUC0-t, AUC0-inf, AUC0-30min and AUC0-2h of plasma concentrations of DHE and 8'-OH-DHE of DHE and its metabolite
Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Tidsramme: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Cmax of plasma concentrations of DHE and 8'-OH-DHE
Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Tidsramme: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Tmax of plasma concentrations of DHE and 8'-OH-DHE
Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Tidsramme: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Kel of plasma concentrations of DHE and 8'-OH-DHE
Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Tidsramme: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
T1/2 el of plasma concentrations of DHE and 8'-OH-DHE
Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Tidsramme: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
CL/F during the terminal phase of DHE
Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Tidsramme: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Vz/F during the terminal phase of DHE
Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Tidsramme: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Change from baseline in FEV1 in absolute value at post-dose time points
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Tidsramme: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Change from baseline in FEV1 in % predicted at post-dose time points
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.

Samarbejdspartnere og efterforskere

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

Sponsor

Aspeya, 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)

26. maj 2026

Primær færdiggørelse (Anslået)

1. marts 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

27. maj 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • VFC202-103

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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