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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later Dec 2026 → Mar 2027
See other at-risk trials from Aspeya, Inc.

Record History

  1. Primary and study completion pushed from Dec 2026 to Mar 2027 Site details revised at 2 of 3 sitesv3 Show 1 more changeShow less
    • Site details revised at 2 of 3 sites
  2. Study sites: 2 to 3 Secondary endpoints: 12 to 14v2 Show 1 more changeShow less
    • Secondary endpoints: 12 to 14

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Aspeya, Inc.
2 trials monitored
See 2 trials at risk
Asthma
927 trials monitored
See 32 trials at risk
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.
Trial Details
NCT Number NCT07665892
Lead Sponsor Aspeya, Inc.
Conditions Safety in Asthma Patients
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov