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 range18 Years – 55 Years

SexALL

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
✕. Known allergic reactions, hypersensitivity or contraindications to DHE, other ergot-derived products or to any excipient
✕. History of drug or alcohol abuse

What they're measuring

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

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

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

Trial details

NCT IDNCT07226362

SponsorAspeya Switzerland SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-02

View on ClinicalTrials.gov More Safety, and Tolerability trials

Who can participate

Age range18 Years – 55 Years

SexALL

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
✕. Known allergic reactions, hypersensitivity or contraindications to DHE, other ergot-derived products or to any excipient
✕. History of drug or alcohol abuse

What they're measuring

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

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

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