Recruiting

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

ClinicalTrials.gov IDNCT07665892

PhasePHASE1

Enrollment40

SponsorAspeya, Inc.

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Safety in Asthma Patients

About this study

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 outcomes

Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma. (Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.)

Eligibility information

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

Study locations

Sun City Clinical Research, Glendale, Arizona 85304 United States
CenExel- Anaheim Clinical trials LLC, Anaheim, California 92801 United States
Worldwide Clinical Trials- Early Phase Research Unit, San Antonio, Texas 78217 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.