Safety in Asthma PatientsPhase 1NCT07665892
Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma
A Phase 1 study testing ASY202 in people with Safety in Asthma Patients, run by Aspeya, Inc. at 3 sites in United States.
Trial summary
This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Safety in Asthma Patients
- What is being tested?
- ASY202
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 May 2026to Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-55 years
- Diagnosed asthma
- Stable asthma treatment
- Non smoker
- BMI 18.5-35 kg/m²
- Women of childbearing potential and men agree to use acceptable contraception
Who cannot join
- Asthma exacerbation requiring systemic steroids, ER visit, or hospitalization within 3 months
- Respiratory tract infection within 4 weeks prior to screening
- Use of oral or IV corticosteroids
- Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids)
- Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry
- Unstable asthma or unresolved safety concerns before dosing
Show all 9Show fewer
- Clinically significant cardiovascular disease or ECG abnormalities contraindicating DHE
- Three or more risk factors for Coronary Artery Disease (CAD) (hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age)
- Pregnancy, breastfeeding, or unwillingness to use required contraception
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 1 recruiting
- Recruiting
CenExel- Anaheim Clinical trials LLC
Anaheim, California, 92801
Amina Z. Haggag, Dr., 714-774-7777 ext. 1012, a.haggag@cenexel.com
Amina Z. Haggag, Dr.
- Active, not recruiting
Sun City Clinical Research
Glendale, Arizona, 85304
- Withdrawn
Worldwide Clinical Trials- Early Phase Research Unit
San Antonio, Texas, 78217
About this study
Official title: A Phase 1 Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single-dose of ASY202 in Adults With Asthma
This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma.
Following screening, eligible participants will be enrolled and randomized to one of two treatment sequences. Participants will receive a single inhaled dose of ASY202 and a single inhaled dose of placebo, each administered once during separate study periods.
Read more
During each treatment period, subjects will stay in the clinical research unit for safety monitoring and PK assessments, including serial blood sampling, spirometry, vital signs, clinical laboratory tests, and ECGs. Each period will include post dose assessments for up to 24 hours.
Participants will return for their next treatment period after a washout interval to ensure complete clearance of study medication. All subjects will receive both treatments over the course of the study.
A follow-up visit will occur after the last dose to assess ongoing safety and tolerability.
- Conditions
- Safety in Asthma Patients
- Being tested
- ASY202, Placebo
- Keywords
- DHE, Dihydroergotamine Mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASY202Combination product
ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI).
PlaceboCombination product
Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.
| Study group | Role | What they receive |
|---|---|---|
| ASY202, then placebo | Experimental | ASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device. Receives: Combination Product: ASY202; Combination Product: Placebo |
| Placebo, then ASY202 | Experimental | In Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2. Receives: Combination Product: ASY202; Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.
Percentage change from baseline in FEV1 over time measured by spirometry at predefined timepoints post-dose (5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours), following administration of investigational product.
Measured: Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.
Secondary outcomes (14)
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Change from baseline in FEV1 in absolute value at post-dose time points
Measured: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Change from baseline in FEV1 in % predicted at post-dose time points
Measured: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Change from baseline in FVC at any of the post-dose time points.
Measured: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Change from baseline in FEV1/FVC ratio at any of the post-dose time points
Measured: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Change from baseline in FEF 25-75 at any of the post-dose time points
Measured: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma
Proportion of participants with ≥20%, ≥15%, ≥10% reduction in FEV1 from baseline at any of the post-dose time points.
Measured: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of a single dose of ASY202 2 mg compared with placebo in adults with asthma.
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 24 hours post dose and safety follow up to seven days after last dose
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
AUC0-t, AUC0-inf, AUC0-30min and AUC0-2h of plasma concentrations of DHE and 8'-OH-DHE of DHE and its metabolite
Measured: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Cmax of plasma concentrations of DHE and 8'-OH-DHE
Measured: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Tmax of plasma concentrations of DHE and 8'-OH-DHE
Measured: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Kel of plasma concentrations of DHE and 8'-OH-DHE
Measured: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
T1/2 el of plasma concentrations of DHE and 8'-OH-DHE
Measured: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
CL/F during the terminal phase of DHE
Measured: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Vz/F during the terminal phase of DHE
Measured: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start26 May 2026
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety in Asthma PatientsStudies 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 participants will be randomized to one of two treatment sequences per the crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspeya, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07665892
- Sponsor's protocol ID
- VFC202-103
- Status last verified
- Sep 2026
- First submitted
- 27 May 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomized, Double-blind, Placebo-controlled, Crossover Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single-dose of ASY202 in Adults With Asthma
- ClinicalTrials.gov ID
- NCT07665892
- Acronym / sponsor ID
- VFC202-103
- Conditions
- Safety in Asthma Patients
- Keywords
- DHE, Dihydroergotamine Mesylate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aspeya, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 May 2026 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 24 Jun 2026 (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.
This is a phase 1 study, randomized, double-blind, placebo-controlled, 2 treatment, 2 period crossover study to evaluate the pharmacokinetics, safety, and tolerability of a single inhaled dose of ASY202 in adults with stable asthma.
Following screening, eligible participants will be enrolled and randomized to one of two treatment sequences. Participants will receive a single inhaled dose of ASY202 and a single inhaled dose of placebo, each administered once during separate study periods.
During each treatment period, subjects will stay in the clinical research unit for safety monitoring and PK assessments, including serial blood sampling, spirometry, vital signs, clinical laboratory tests, and ECGs. Each period will include post dose assessments for up to 24 hours.
Participants will return for their next treatment period after a washout interval to ensure complete clearance of study medication. All subjects will receive both treatments over the course of the study.
A follow-up visit will occur after the last dose to assess ongoing safety and tolerability.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Eligible participants will be randomized to one of two treatment sequences per the crossover design
| Arm | Type | Receives |
|---|---|---|
| ASY202, then placebo | Experimental | Combination Product: ASY202, Combination Product: PlaceboASY202 is a pre-metered drug-device combination product containing DHE dry powder formulation for oral inhalation, delivered via a dry powder inhaler (DPI) device. In Treatment Period 1, participants will receive ASY202, followed by a washout period and subsequent administration of placebo in Treatment Period 2. The placebo consists of an inactive inhalation powder delivered via a matching DPI device. |
| Placebo, then ASY202 | Experimental | Combination Product: ASY202, Combination Product: PlaceboIn Treatment Period 1, participants will receive placebo inhalation powder delivered via a dry powder inhaler (DPI) device, followed by a washout period and subsequent administration of ASY202 in Treatment Period 2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18-55 years
- Diagnosed asthma
- Stable asthma treatment
- Non smoker
- BMI 18.5-35 kg/m²
Key exclusion criteria (9 listed)
- Asthma exacerbation requiring systemic steroids, ER visit, or hospitalization within 3 months
- Respiratory tract infection within 4 weeks prior to screening
- Use of oral or IV corticosteroids
- Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids)
- Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry
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 |
|---|---|---|
| ASY202ASY202 is a pre-metered drug-device combination product containing a dry-powder formulation of dihydroergotamine (DHE) intended for oral inhalation, delivered via a dry powder inhaler (DPI). | Combination product | ASY202, then placebo, Placebo, then ASY202 |
| PlaceboPlacebo inhalation powder delivered via a dry powder inhaler (DPI) device. | Combination product | ASY202, then placebo, Placebo, then ASY202 |
Primary outcome
Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma.
Time frame: Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.
Percentage change from baseline in FEV1 over time measured by spirometry at predefined timepoints post-dose (5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours), following administration of investigational product.
14 secondary outcomes
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Time frame: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Time frame: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Time frame: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours.
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Time frame: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma.
Time frame: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Effect of a single dose of ASY202 2 mg compared with placebo on additional pulmonary function in adults with asthma
Time frame: Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of a single dose of ASY202 2 mg compared with placebo in adults with asthma.
Time frame: Up to 24 hours post dose and safety follow up to seven days after last dose
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Time frame: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Time frame: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma.
Time frame: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Time frame: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Time frame: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Time frame: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Characterization of the PK of DHE and its major metabolite 8'-OH-DHE after administration of single dose of DHE inhalation powder in adults with asthma
Time frame: Multiple post-dose timepoints: 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours and 24 hours, following study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASY202 in people with Safety in Asthma Patients, run by Aspeya, Inc. at 3 sites 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: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Crespel (+ 41 78 688 05 43, clinicaltrials@aspeya.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma. (time frame: Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours.). 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 2 Sep 2026.