A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults (NCT07226362) | Clinical Trial Compass
CompletedPhase 1
A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults
United States44 participantsStarted 2025-06-09
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pharmacokinetics: Area under the curve (AUC 0-t) of DHE
Timeframe: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours
2
Pharmacokinetics: Area under the curve (AUC 0-inf) of DHE
Timeframe: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours
3
Pharmacokinetics: Peak plasma concentration (C max) of DHE
Timeframe: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours