RecruitingPhase 1NCT07665892

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


Sponsor

Aspeya, Inc.

Enrollment

40 participants

Start Date

May 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying ASY202 and Placebo for people with safety in asthma patients. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTASY202

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_PRODUCTPlacebo

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


Locations(3)

Sun City Clinical Research

Glendale, Arizona, United States

CenExel- Anaheim Clinical trials LLC

Anaheim, California, United States

Worldwide Clinical Trials- Early Phase Research Unit

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07665892