Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma
ConditionSafety in Asthma Patients
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAspeya, Inc.
About this trial
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 criteria
Qualifiers
Adults aged 18-55 years
Diagnosed asthma
Stable asthma treatment
Non smoker
Disqualifiers
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)
Trial design
Treatments tested in this trial
- ASY202
- Placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov