Safety, and TolerabilityPhase 1NCT07226362
A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults
A Phase 1 study testing DHE inhalation powder low dose administered via dry powder inhaler (DPI) device, DHE inhalation powder high dose administered via dry powder inhaler (DPI) device and DHE injected intravenously (1 mg) in people with Safety, and Tolerability, run by Aspeya Switzerland SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, and Tolerability
- What is being tested?
- DHE inhalation powder low dose administered via dry powder inhaler (DPI) device, DHE inhalation powder high dose administered via dry powder inhaler (DPI) device and DHE injected intravenously (1 mg)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2025to 2 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Alliance for Multispecialty research (AMR)
Knoxville, Tennessee, 37920
About this study
Official title: 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.
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.
Read the 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
- Being tested
- DHE inhalation powder low dose administered via dry powder inhaler (DPI) device, DHE inhalation powder high dose administered via dry powder inhaler (DPI) device, DHE injected intravenously (1 mg), DHE 2 mg administered by nasal spray (Migranal®), Metoclopramide 10mg
- Keywords
- Dihydroergotamine mesylate, Inhalation powder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DHE inhalation powder low dose administered via dry powder inhaler (DPI) deviceCombination product
The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder low dose formulation for oral inhalation
DHE inhalation powder high dose administered via dry powder inhaler (DPI) deviceCombination product
The DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder high dose formulation for oral inhalation
DHE injected intravenously (1 mg)Drug
A single dose of DHE injection consists of 1 mg/mL ampoule of DHE solution for slow intravenous administration.
DHE 2 mg administered by nasal spray (Migranal®)Drug
A single vial of DHE nasal spray (Migranal®) contains 1 mL of 4 mg/mL DHE solution.
Metoclopramide 10mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A: inhaled DHE low dose | Experimental | Low dose of DHE inhalation powder Receives: Combination Product: DHE inhalation powder low dose administered via dry powder inhaler (DPI) device |
| Treatment B: inhaled DHE high dose | Experimental | High dose of DHE inhalation powder Receives: Combination Product: DHE inhalation powder high dose administered via dry powder inhaler (DPI) device |
| Treatment C: intravenous DHE | Active comparator | 1 mg DHE injected intravenously Receives: Drug: DHE injected intravenously (1 mg); Drug: Metoclopramide 10mg |
| Treatment D: intranasal DHE | Active comparator | 2 mg DHE nasal spray (Migranal®) Receives: Drug: DHE 2 mg administered by nasal spray (Migranal®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area under the curve (AUC 0-t) of DHE
Area under the concentration-time curve from time zero until the last observed plasma concentration of DHE (AUC 0-t)
Measured: 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
Area under the concentration-time curve from time zero to infinity (extrapolated) of plasma concentrations of DHE (AUC 0-inf)
Measured: 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
Maximal observed plasma concentration of DHE (C max)
Measured: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours
Secondary outcomes (25)
Pharmacokinetics: Area under the curve (AUC 0-t) of 8'-OH-DHE
Area under the concentration-time curve from time zero until the last observed plasma concentration of 8'-OH-DHE (AUC 0-t)
Measured: 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 8'-OH-DHE
Area under the concentration-time curve from time zero to infinity (extrapolated) of plasma concentrations of 8'-OH-DHE (AUC 0-inf)
Measured: 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 8'-OH-DHE
Maximal plasma observed concentration of 8'-OH-DHE (C max)
Measured: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Time of peak maximal concentration (T max) of DHE and 8'-OH-DHE
Time when the maximal plasma concentration of DHE and 8'-OH-DHE are observed (T max)
Measured: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Terminal elimination half-life (T 1/2 el) of DHE and 8'-OH-DHE
Terminal elimination half-life of plasma concentrations of DHE and 8'-OH-DHE (T 1/2 el)
Measured: 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 0-30 min) of DHE
Area under the concentration-time curve from time zero to 30 min of plasma concentrations of DHE (AUC 0-30min)
Measured: 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 0-2 hours) of DHE
Area under the concentration-time curve from time zero to 2 hours of plasma concentrations of DHE (AUC 0-2 hours)
Measured: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Apparent clearance of DHE (CL/F)
Apparent clearance of DHE (CL/F) for DHE inhalation powder and DHE nasal spray Migranal®
Measured: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Clearance of DHE (CL)
Clearance of DHE for intravenous DHE (CL)
Measured: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Apparent volume of distribution of DHE (Vz/F)
Apparent volume of distribution (Vz/F) during terminal phase of DHE for DHE inhalation powder and DHE nasal spray Migranal®
Measured: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Volume of distribution of DHE (Vz)
Volume of distribution (Vz) of DHE intravenous
Measured: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Safety: Number of participants with adverse events
Adverse events will be recorded and evaluated for their seriousness, severity and relationship to the study drug
Measured: From the time of signing the informed consent until the last visit on Day 7 after the last treatment period
Safety: Blood pressure in mmHg
The changes from baseline in systolic and diastolic blood pressure will be assessed
Measured: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods
Safety: Heart rate in beats/min
The changes from baseline in heart rate will be assessed
Measured: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods
Safety: Respiratory rate in breaths/min
The changes from baseline in respiratory rate will be assessed
Measured: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods
Safety: Oral body temperature in degree Celsius
The changes from baseline in oral body temperature will be assessed
Measured: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods
ECG PR interval in msec
The changes from baseline in 12-lead ECG PR interval will be assessed
Measured: Baseline and post-dose measurements from 10 minutes up to 4 hours for each of the 4 treatment periods
ECG QRS complex in msec
The changes from baseline in 12-lead ECG QRS complex will be assessed
Measured: Baseline and post-dose measurements from 10 minutes up to 4 hours for each of the 4 treatment periods
ECG QT interval in msec
The changes from baseline in 12-lead ECG QT interval and Fridericia's corrected QT interval will be assessed
Measured: Baseline and post-dose measurements from 10 minutes up to 4 hours for each of the 4 treatment periods
Physical examination
Physical examination (including oral cavity, nasal cavity and injection site examination) will be performed
Measured: At screening, and for each of the 4 treatment periods at baseline, and post-dose at day 2 and day 3
Lung function by spirometry : Forced Expiratory Volume in 1 sec in % of predicted normal (FEV1 )
Effect of DHE on lung function will be measured by collecting FEV 1 pre- and post-dose at specified timepoints and will be analyzed by FEV1 < 70 % of predicted normal and/or comparison of pre- and post-dose > 20 % decline in FEV1.
Measured: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Lung function by spirometry : Forced Vital Capacity (FVC) in liters
Effect of DHE on lung function will be measured by collecting Forced Vital Capacity pre- and post-dose at specified timepoints
Measured: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Lung function by spirometry : FEV1/FVC ratio
Effect of DHE on lung function will be measured by collecting the FEV1/FVC ratio pre- and post-dose at specified timepoints
Measured: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Lung function by spirometry : Forced Expiratory Flow 25-75 in %
Effect of DHE on lung function will be measured by collecting the mean Forced expiratory Flow between 25% and 75% of the forced vital capacity pre- and post-dose at specified timepoints
Measured: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Clinical laboratory tests blood and urine
Change from baseline in clinical laboratory tests (including hematology, biochemistry, coagulation, and urinalysis) will be analyzed at different timepoints
Measured: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start9 Jun 2025
- Primary completion2 Oct 2025
- Study completion2 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety, and TolerabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Eligible subjects will be enrolled and randomized on Day 1 to one of the 4 treatment sequences composed of 4 periods of the crossover design.
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspeya Switzerland SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226362
- Sponsor's protocol ID
- VFC202-102
- Status last verified
- Mar 2026
- First submitted
- 28 Oct 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07226362
- Acronym / sponsor ID
- VFC202-102
- Conditions
- Safety, and Tolerability
- Keywords
- Dihydroergotamine mesylate, Inhalation powder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Aspeya Switzerland SAIndustry (pharma, biotech, devices)
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 2 Oct 2025 (actual)
- Study completion
- 2 Oct 2025 (actual)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Eligible subjects will be enrolled and randomized on Day 1 to one of the 4 treatment sequences composed of 4 periods of the crossover design.
| Arm | Type | Receives |
|---|---|---|
| Treatment A: inhaled DHE low dose | Experimental | Combination Product: DHE inhalation powder low dose administered via dry powder inhaler (DPI) deviceLow dose of DHE inhalation powder |
| Treatment B: inhaled DHE high dose | Experimental | Combination Product: DHE inhalation powder high dose administered via dry powder inhaler (DPI) deviceHigh dose of DHE inhalation powder |
| Treatment C: intravenous DHE | Active comparator | Drug: DHE injected intravenously (1 mg), Drug: Metoclopramide 10mg1 mg DHE injected intravenously |
| Treatment D: intranasal DHE | Active comparator | Drug: DHE 2 mg administered by nasal spray (Migranal®)2 mg DHE nasal spray (Migranal®) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must meet all the following criteria to be included in the study:
Key exclusion criteria (9 listed)
- Subjects to whom any of the following applies will be excluded from the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DHE inhalation powder low dose administered via dry powder inhaler (DPI) deviceThe DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder low dose formulation for oral inhalation | Combination product | Treatment A: inhaled DHE low dose |
| DHE inhalation powder high dose administered via dry powder inhaler (DPI) deviceThe DHE inhalation powder is a pre-metered drug-device combination product containing DHE dry powder high dose formulation for oral inhalation | Combination product | Treatment B: inhaled DHE high dose |
| 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 | Treatment C: intravenous DHE |
| 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 | Treatment D: intranasal DHE |
| Metoclopramide 10mgTo 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. | Drug | Treatment C: intravenous DHE |
Primary outcome
Pharmacokinetics: Area under the curve (AUC 0-t) of DHE
Time frame: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours
Area under the concentration-time curve from time zero until the last observed plasma concentration of DHE (AUC 0-t)
Pharmacokinetics: Area under the curve (AUC 0-inf) of DHE
Time frame: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours
Area under the concentration-time curve from time zero to infinity (extrapolated) of plasma concentrations of DHE (AUC 0-inf)
Pharmacokinetics: Peak plasma concentration (C max) of DHE
Time frame: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours
Maximal observed plasma concentration of DHE (C max)
25 secondary outcomes
Pharmacokinetics: Area under the curve (AUC 0-t) of 8'-OH-DHE
Time frame: 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 8'-OH-DHE
Time frame: 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 8'-OH-DHE
Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Time of peak maximal concentration (T max) of DHE and 8'-OH-DHE
Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Terminal elimination half-life (T 1/2 el) of DHE and 8'-OH-DHE
Time frame: 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 0-30 min) of DHE
Time frame: 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 0-2 hours) of DHE
Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Apparent clearance of DHE (CL/F)
Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Clearance of DHE (CL)
Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Apparent volume of distribution of DHE (Vz/F)
Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Pharmacokinetics: Volume of distribution of DHE (Vz)
Time frame: For each of the 4 treatment periods on Baseline and post-dose measurements from 2 minutes up to 48 hours
Safety: Number of participants with adverse events
Time frame: From the time of signing the informed consent until the last visit on Day 7 after the last treatment period
Safety: Blood pressure in mmHg
Time frame: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods
Safety: Heart rate in beats/min
Time frame: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods
Safety: Respiratory rate in breaths/min
Time frame: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods
Safety: Oral body temperature in degree Celsius
Time frame: Baseline and post-dose measurements from 10 minutes up to 48 hours for each of the 4 treatment periods
ECG PR interval in msec
Time frame: Baseline and post-dose measurements from 10 minutes up to 4 hours for each of the 4 treatment periods
ECG QRS complex in msec
Time frame: Baseline and post-dose measurements from 10 minutes up to 4 hours for each of the 4 treatment periods
ECG QT interval in msec
Time frame: Baseline and post-dose measurements from 10 minutes up to 4 hours for each of the 4 treatment periods
Physical examination
Time frame: At screening, and for each of the 4 treatment periods at baseline, and post-dose at day 2 and day 3
Lung function by spirometry : Forced Expiratory Volume in 1 sec in % of predicted normal (FEV1 )
Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Lung function by spirometry : Forced Vital Capacity (FVC) in liters
Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Lung function by spirometry : FEV1/FVC ratio
Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Lung function by spirometry : Forced Expiratory Flow 25-75 in %
Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Clinical laboratory tests blood and urine
Time frame: At screening, and for each of the 4 treatment periods at pre-dose, and post-dose up to 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DHE inhalation powder low dose administered via dry powder inhaler (DPI) device, DHE inhalation powder high dose administered via dry powder inhaler (DPI) device and DHE injected intravenously (1 mg) in people with Safety, and Tolerability, run by Aspeya Switzerland SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: Area under the curve (AUC 0-t) of DHE (time frame: For each of the 4 treatment periods on baseline and post-dose measurements from 2 minutes up to 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.