NCT07665892RecruitingPhase 1
Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma
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
Source: ClinicalTrials.gov · Last updated 2 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 27 May 2026
- Start date
- 26 May 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Aspeya, Inc.
- Diseases
- Asthma
- NCT number
- NCT07665892
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 26 May 2026 to the primary completion date, Mar 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry
- Clinically significant cardiovascular disease or ECG abnormalities contraindicating DHE
Lab values
- Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids)
Age
- 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)
Other
- Unstable asthma or unresolved safety concerns before dosing
- Pregnancy, breastfeeding, or unwillingness to use required contraception
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CenExel- Anaheim Clinical trials LLC Coordinator of this site? Confirm its status | Anaheim | United States | Recruiting |
| Sun City Clinical Research Coordinator of this site? Confirm its status | Glendale | United States | Active, not recruiting |
| Worldwide Clinical Trials- Early Phase Research Unit Coordinator of this site? Confirm its status | San Antonio | United States | Withdrawn |
This page is information, not medical advice. Discuss any trial with your doctor.