NCT07226362

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

A Phase-1, Open-label Randomized, 4-treatment, 4-period Crossover Study to Evaluate the Pharmacokinetics, Relative Bioavailability, Safety and Tolerability of Single Doses of Dihydroergotamine Mesylate (DHE) Inhalation Powder, DHE Intravenous (IV), and DHE Nasal Spray in Healthy Adult Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Aspeya Switzerland SA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Safety, and Tolerability

Interventions

Type	Name	Description
COMBINATION_PRODUCT	DHE inhalation powder low dose administered via dry powder inhaler (DPI) device	The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder low dose formulation for oral inhalation
COMBINATION_PRODUCT	DHE inhalation powder high dose administered via dry powder inhaler (DPI) device	The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder high dose formulation for oral inhalation
DRUG	DHE injected intravenously (1 mg)	A single dose of DHE injection consists of 1 mg/mL ampoule of DHE solution for slow intravenous administration.
DRUG	DHE 2 mg administered by nasal spray (Migranal®)	A single vial of DHE nasal spray (Migranal®) contains 1 mL of 4 mg/mL DHE solution.
DRUG	Metoclopramide 10mg	To prevent nausea caused by IV administration of DHE, participants will receive antiemetic pre-medication with metoclopramide 10 mg administered by slow intravenous push over 1-2 min, given 5 to 10 minutes prior to IV DHE dosing.

Timeline

• Start date: 2025-06-09
• Primary completion: 2025-10-02
• Completion: 2025-10-02
• First posted: 2025-11-10
• Last updated: 2026-03-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study