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

Condition(s) studied

Investigational drug(s) / intervention(s)

ASY202: 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).

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

Study 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

Primary outcome measure(s)

• Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma. — Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.
  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.

Trial sites (3)

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