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

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.

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