[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Aspeya, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100644075","phase-1-phase-1-study-evaluating-safety-and-pharmacokinetics-of-asy202-in-adults-with-asthma-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":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Safety in Asthma Patients",[29,30],"DHE","Dihydroergotamine Mesylate","RECRUITING","2026-06-18",{"date":34,"type":35},"2026-06-24","ACTUAL",{"date":37,"type":35},"2026-05-26",{"date":39,"type":21},"2026-12",{"name":41,"class":42},"Aspeya, Inc.","INDUSTRY",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":65,"locationsCount":66},"100642292","phase-2-study-evaluating-the-efficacy-safety-and-tolerability-of-asy202-dihydroergotamine-mesylate-dhe-inhalation-powder-delivered-via-a-multidose-dry-powder-inhaler-for-the-acute-treatment-of-migraine-in-adult-patients-100642292","NCT07646613","Study Evaluating the Efficacy, Safety, and Tolerability of ASY202 (Dihydroergotamine Mesylate [DHE] Inhalation Powder Delivered Via a Multidose Dry Powder Inhaler) for the Acute Treatment of Migraine in Adult Patients","A Randomized, Double-blind, Placebo-controlled, Crossover, Multi-center Clinical Trial for the Evaluation of Efficacy, Safety, and Tolerability of ASY202 for the Acute Treatment of Migraine in Adult Patients","Inclusion Criteria:\n\n* Able to understand study procedures and provide written informed consent\n* Male or female, 18-65 years of age at Screening\n* BMI between 18.5-35 kg\u002Fm² at Screening\n* Documented history of migraine (with or without aura) for ≥1 year, consistent with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)\n* Female participants must be either:\n\n  * of non-childbearing potential, or\n  * of childbearing potential using protocol required contraception\n\nExclusion Criteria:\n\n* Diagnosis of headache conditions other than migraine\n* History or current diagnosis of coronary artery disease (CAD)\n* History or current diagnosis of coronary artery vasospasm (including Printz-metal's angina), clinically significant arrhythmia (e.g., ventricular tachycardia, ventricular fibrillation) or peripheral vascular disease, ischemic disease (e.g., Raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia)\n* History of percutaneous coronary intervention, cardiac surgery, sepsis or vascular surgery\n* History or current diagnosis of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, or subarachnoid hemorrhage\n* Known history or current diagnosis of psychological and\u002For psychiatric condition that, in the opinion of the Investigator, might interfere with study participation and assessments or participant safety. These conditions may include depression, psychosis, schizophrenia, bipolar disorder, dementia, alcoholism, drug abuse, etc.\n* Known allergic reactions, hypersensitivity, or contraindications to DHE, other ergot-derived products, or any other excipient in the formulation\n* Use of strong or moderate CYP3A4 inhibitors within 14 days (or 5 half-lives) or CYP3A4 inducers within 28 days (or 5 half-lives) prior to Randomization\n* Any clinically significant symptoms or conditions at screening, other than migraine, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions, or history of such conditions that in the opinion of the Investigator, might interfere with study assessments or participant safety","65 Years",{"count":52,"type":21},108,[54],"PHASE2","This study is testing an investigational inhaled migraine medication to see how well it works, how safe it is, and how well people tolerate it. Adults with migraine will receive both the study medication (ASY202) and a placebo (inactive treatment) at different times during the study. Neither participants nor study staff will know which treatment is given at the time. The medication is taken using a handheld dry powder inhaler to treat migraine attacks when they occur.\n\nFollowing screening, eligible participants will be enrolled and randomized to one of two treatments sequences i.e. one treatment sequence will receive ASY202 in treatment period 1 followed by placebo in treatment period 2 and other treatment sequence will receive placebo in treatment period 1 followed by ASY202 in treatment period 2.\n\nThe study lasts about 16 weeks and includes a screening period, two treatment periods (with a minimum of 7 days washout period between the treatment periods), and a safety follow-up visit.",[57],"Migraine",[57,29,30],"2026-06-15",{"date":61,"type":35},"2026-06-16",{"date":63,"type":35},"2026-05-19",{"date":39,"type":21},{"name":41,"class":42},3,""]