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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASY202 | Combination 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of a single dose of ASY202 2 mg compared with placebo on pulmonary function in adults with asthma. | Mean 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. | Post dose 5 minutes, 15 minutes, 40 minutes, 1hour, 2 hours and 4 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guillaume Crespel | Contact | + 41 78 688 05 43 | clinicaltrials@aspeya.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun City Clinical Research | Recruiting | Glendale | Arizona | 85304 | United States |
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Eligible participants will be randomized to one of two treatment sequences per the crossover design
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| Placebo | Combination Product | Placebo inhalation powder delivered via a dry powder inhaler (DPI) device. |
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Change from baseline in FEV1/FVC ratio at any of the post-dose time points |
| 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 | 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. | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Worldwide Clinical Trials- Early Phase Research Unit | Recruiting | San Antonio | Texas | 78217 | United States |
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