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Recruiting NCT07665892

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

Phase I Interventional Safety in Asthma Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ASY202, Placebo.
Who it may be relevant to
Registry conditions: Safety in Asthma Patients. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • 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.]
Secondary outcome measures (12)
  • 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.]
  • 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.]
  • 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.]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 3 centers
  • Sun City Clinical Research — Glendale
  • CenExel- Anaheim Clinical trials LLC — Anaheim
  • Worldwide Clinical Trials- Early Phase Research Unit — San Antonio

Identifiers

NCT: NCT07665892 · VFC202-103

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗