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

1. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

40

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Arizona
      • Glendale, Arizona, Vereinigte Staaten, 85304
        • Aktiv, nicht rekrutierend
        • Sun City Clinical Research
    • California
      • Anaheim, California, Vereinigte Staaten, 92801
        • Rekrutierung
        • CenExel- Anaheim Clinical trials LLC
        • Kontakt:
        • Hauptermittler:
          • Amina Z. Haggag, Dr.
    • Texas
      • San Antonio, Texas, Vereinigte Staaten, 78217
        • Zurückgezogen
        • Worldwide Clinical Trials- Early Phase Research Unit

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Verdreifachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Experimental: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aspeya, Inc.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Mai 2026

Primärer Abschluss (Geschätzt)

1. März 2027

Studienabschluss (Geschätzt)

1. März 2027

Studienanmeldedaten

Zuerst eingereicht

27. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2026

Zuerst gepostet (Tatsächlich)

24. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

2. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

1. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • VFC202-103

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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