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NCT Number: NCT07665892

Phase 1 Study Evaluating Safety and Pharmacokinetics 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.

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Key information

Conditions

Safety in Asthma Patients

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun City Clinical Research, Glendale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASY202

Combination Product

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).

Placebo

Combination Product

Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.

Primary outcomes

  1. Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.

    Time frame: 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.

Secondary outcomes

  1. Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.

    Time frame: 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

  2. Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.

    Time frame: 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

  3. Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.

    Time frame: 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.

  4. Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.

    Time frame: 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

  5. Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.

    Time frame: 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

  6. Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma

    Time frame: 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.

  7. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of a single dose of ASY202 2 mg compared with placebo in adults with asthma.

    Time frame: 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)

  8. 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.

    Time frame: 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

  9. 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.

    Time frame: 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

  10. 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.

    Time frame: 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

  11. 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

    Time frame: 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

  12. 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

    Time frame: 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

  13. 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

    Time frame: 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

  14. 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Crespel

CONTACT

[email protected]

+ 41 78 688 05 43

Sponsors and collaborators

Lead sponsor

Aspeya, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.