NCT07665892 · Aspeya, Inc.
Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma
What this study is about
This is a phase 1 study, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, 2 treatment, 2 period crossover study to evaluate the how the drug moves through the body, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma.
View original scientific description
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.
Mean 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Adults aged 18-55 years
- Diagnosed asthma
- Stable asthma treatment
- 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
Where
- Glendale, Arizona
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 24, 2026 · Source of record for eligibility and locations