A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults

A Phase 1 clinical trial to evaluate the pharmacokinetics, relative bioavailability, safety and tolerability of DHE inhalation powder delivered by dry powder inhaler, DHE IV, and DHE nasal spray.

This is an open-label, randomized, 4-treatment, 4-period crossover study to evaluate the PK, relative BA, safety, and tolerability of single doses of study medication in healthy adult subjects. Following screening, eligible subjects will be enrolled and randomized to one of the 4 treatment sequences. Subjects will receive single doses of DHE inhalation powder (low dose and high dose), DHE IV (1 mg) and DHE nasal spray (2 mg). Subjects will be administered one treatment in each period according to their assigned sequence. Each subject will receive all 4 treatments in the study. During each treatment period subjects will remain in the clinical research unit for 3 days, until completion of the 48-hour post-dose assessments. Subjects will return for their next treatment period after at least 7 days washout after the administration of their previous treatment until all periods have been completed in their sequence. A follow-up will be conducted on Day 7 after the last dose in the study to assess safety.