A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults
Completed · Phase 1
Conditions studied: Safety, and Tolerability
In brief
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.
Key facts
- Study ID
- NCT07226362
- Run by
- Aspeya Switzerland SA
- People needed
- 44
- Starts
- 2025-06-09
- Expected to finish
- 2025-10-02
- Last updated by the study team
- 2026-03-19
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subjects must meet all the following criteria to be included in the study:
- Male or female, ≥ 18 and ≤ 55 years of age, with body mass index (BMI) >18.5 and < 32.0 kg/m2
- Healthy subjects
- Female subjects of non-childbearing potential or childbearing potential willing to use protocol required methods of contraception
- Current non-smoker
- Able to understand the study procedures and provide signed informed consent to participate in the study.
You may not qualify if…
- Subjects to whom any of the following applies will be excluded from the study:
- Positive pregnancy test or lactating female subjects at screening or on Day 1 of each treatment period
- Clinically significant abnormal laboratory or serology test results
- History or current diagnosis of uncontrolled or significant cardiac disease
- Significant risk factors for cardiovascular disease
- Subject with abnormal lung function at screening
- History or current diagnosis of lung disease e.g. asthma, COPD
- Known allergic reactions, hypersensitivity or contraindications to DHE, other ergot-derived products or to any excipient
- History of drug or alcohol abuse
Where it is running
- Alliance for Multispecialty research (AMR) — Knoxville, Tennessee, United States
Full record on ClinicalTrials.gov
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