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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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Sun City Clinical Research
ACTIVE_NOT_RECRUITING
Glendale
California
CenExel- Anaheim Clinical trials LLC
RECRUITING
Anaheim
Texas
Worldwide Clinical Trials- Early Phase Research Unit
WITHDRAWN
San Antonio
Contact Information
Primary
Guillaume Crespel
clinicaltrials@aspeya.com
+ 41 78 688 05 43
Time Frame
Start Date: 2026-05-26
Estimated Completion Date: 2027-03
Participants
Target number of participants: 40
Treatments
Experimental: ASY202, then placebo
ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device.
Experimental: Placebo, then ASY202
In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2.
Related Therapeutic Areas
Sponsors
Leads: Aspeya, Inc.

This content was sourced from clinicaltrials.gov

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