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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
ASY202
Combination productASY202 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).
Placebo
Combination productPlacebo inhalation powder delivered via a dry powder inhaler (DPI) device.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ASY202, then placeboExperimental treatment 2 interventions
Group B: Placebo, then ASY202Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.
Percentage change from baseline in FEV1 over time measured by spirometry at predefined timepoints post-dose (5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours), following administration of investigational product.
Time frame
Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.Secondary outcomes
1
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Change from baseline in FEV1 in absolute value at post-dose time points
Time frame
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.2
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Change from baseline in FEV1 in % predicted at post-dose time points
Time frame
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.3
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Change from baseline in FVC at any of the post-dose time points.
Time frame
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.4
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Change from baseline in FEV1/FVC ratio at any of the post-dose time points
Time frame
Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hoursSponsors and contacts
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Source ClinicalTrials.gov