[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644075":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":47,"studyPopulation":47,"armGroups":59,"interventions":71,"overallOfficials":47,"centralContacts":81,"locations":87,"responsibleParty":125,"collaborators":47,"id":127,"slug":47,"hasResults":128,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":47,"eligibilityCriteria":132,"healthyVolunteers":128,"sex":133,"minAge":134,"maxAge":135,"enrollmentInfo":136,"targetDuration":47,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":90,"whyStopped":47,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Aspeya, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"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.",[14,18,21,23,26,30,34,36,38,41,43,45],{"measure":15,"description":16,"timeFrame":17},"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.",{"measure":15,"description":19,"timeFrame":20},"Change from baseline in FEV1\u002FFVC ratio at any of the post-dose time points","Post dose 5 minutes, 15 minutes, 40 minutes, 1 hour, 2 hours and 4 hours",{"measure":15,"description":22,"timeFrame":20},"Change from baseline in FEF 25-75 at any of the post-dose time points",{"measure":24,"description":25,"timeFrame":20},"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.",{"measure":27,"description":28,"timeFrame":29},"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",{"measure":31,"description":32,"timeFrame":33},"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",{"measure":31,"description":35,"timeFrame":33},"Cmax of plasma concentrations of DHE and 8'-OH-DHE",{"measure":31,"description":37,"timeFrame":33},"Tmax of plasma concentrations of DHE and 8'-OH-DHE",{"measure":39,"description":40,"timeFrame":33},"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",{"measure":39,"description":42,"timeFrame":33},"T1\u002F2 el of plasma concentrations of DHE and 8'-OH-DHE",{"measure":39,"description":44,"timeFrame":33},"CL\u002FF during the terminal phase of DHE",{"measure":39,"description":46,"timeFrame":33},"Vz\u002FF during the terminal phase of DHE",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":47,"timePerspective":47,"maskingInfo":53},"RANDOMIZED","CROSSOVER","Eligible participants will be randomized to one of two treatment sequences per the crossover design","BASIC_SCIENCE",{"masking":54,"maskingDescription":47,"whoMasked":55},"TRIPLE",[56,57,58],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[60,67],{"label":61,"type":62,"description":63,"interventionNames":64},"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.",[65,66],"Combination Product: ASY202","Combination Product: Placebo",{"label":68,"type":62,"description":69,"interventionNames":70},"Placebo, then ASY202","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.",[65,66],[72,77],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":47},"COMBINATION_PRODUCT","ASY202","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).",[61,68],{"type":73,"name":78,"description":79,"armGroupLabels":80,"otherNames":47},"Placebo","Placebo inhalation powder delivered via a dry powder inhaler (DPI) device.",[61,68],[82],{"name":83,"role":84,"phone":85,"phoneExt":47,"email":86},"Guillaume Crespel","CONTACT","+ 41 78 688 05 43","clinicaltrials@aspeya.com",[88,109],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"countryCode":95,"cosmosGeoPoint":96,"geoPoint":101,"contacts":102},"Sun City Clinical Research","RECRUITING","Glendale","Arizona","85304","United States","US",{"type":97,"coordinates":98},"Point",[99,100],-112.18599,33.53865,{"lat":100,"lon":99},[103,107],{"name":104,"role":84,"phone":105,"phoneExt":47,"email":106},"Jan Watson, Dr.","623- 253-9777","jwatson@suncitytrials.com",{"name":104,"role":108,"phone":47,"phoneExt":47,"email":47},"PRINCIPAL_INVESTIGATOR",{"facility":110,"status":90,"city":111,"state":112,"zip":113,"country":94,"countryCode":95,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Worldwide Clinical Trials- Early Phase Research Unit","San Antonio","Texas","78217",{"type":97,"coordinates":115},[116,117],-98.49363,29.42412,{"lat":117,"lon":116},[120,124],{"name":121,"role":84,"phone":122,"phoneExt":47,"email":123},"Alan Hand, Dr.","210-635-1500","alan.hand@worldwide.com",{"name":121,"role":108,"phone":47,"phoneExt":47,"email":47},{"type":126,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100644075",false,"NCT07665892","Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma","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","Inclusion Criteria:\n\n* Adults aged 18-55 years\n* Diagnosed asthma\n* Stable asthma treatment\n* Non smoker\n* BMI 18.5-35 kg\u002Fm²\n* Women of childbearing potential and men agree to use acceptable contraception\n\nExclusion Criteria:\n\n* Asthma exacerbation requiring systemic steroids, ER visit, or hospitalization within 3 months\n* Respiratory tract infection within 4 weeks prior to screening\n* Use of oral or IV corticosteroids\n* Use of prohibited medications (e.g., CYP3A4 modulators, triptans, vasoconstrictors, QT prolongers, theophylline, systemic steroids)\n* Other lung diseases (e.g., Chronic Obstructive Pulmonary Disease (COPD)) or conditions interfering with spirometry\n* Unstable asthma or unresolved safety concerns before dosing\n* Clinically significant cardiovascular disease or ECG abnormalities contraindicating DHE\n* 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)\n* Pregnancy, breastfeeding, or unwillingness to use required contraception","ALL","18 Years","55 Years",{"count":137,"type":138},40,"ESTIMATED","INTERVENTIONAL",[141],"PHASE1","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.\n\nFollowing 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.\n\nDuring 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.\n\nParticipants 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.\n\nA follow-up visit will occur after the last dose to assess ongoing safety and tolerability.",[144],"Safety in Asthma Patients",[146,147],"DHE","Dihydroergotamine Mesylate","2026-06-18",{"date":150,"type":151},"2026-06-24","ACTUAL",{"date":153,"type":151},"2026-05-26",{"date":155,"type":138},"2026-12",{"name":5,"class":6},2]