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

1 settembre 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Glendale, Arizona, Stati Uniti, 85304
        • Attivo, non reclutante
        • Sun City Clinical Research
    • California
      • Anaheim, California, Stati Uniti, 92801
        • Reclutamento
        • CenExel- Anaheim Clinical trials LLC
        • Contatto:
        • Investigatore principale:
          • Amina Z. Haggag, Dr.
    • Texas
      • San Antonio, Texas, Stati Uniti, 78217
        • Ritirato
        • Worldwide Clinical Trials- Early Phase Research Unit

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Prodotto combinato: 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).
Prodotto combinato: Placebo
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
Sperimentale: 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.
Prodotto combinato: 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).
Prodotto combinato: Placebo
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Lasso di tempo: 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.
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Aspeya, Inc.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 maggio 2026

Completamento primario (Stimato)

1 marzo 2027

Completamento dello studio (Stimato)

1 marzo 2027

Date di iscrizione allo studio

Primo inviato

27 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2026

Primo Inserito (Effettivo)

24 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

2 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

1 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • VFC202-103

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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