[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AlphaMol Science Ltd. (Shanghai)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100647013","phase-1-phase-ib-randomized-double-blind-placebo-controlled-dose-escalation-study-of-alpha-0261-tablets-to-assess-safety-and-tolerability-in-patients-with-chronic-spontaneous-urcaria-part-1-and-food-effect-in-healthy-adults-part-2-100647013",false,"NCT07684560","Phase Ib, Randomized, Double-blind, Placebo-Controlled, Dose-Escalation Study of Alpha-0261 Tablets to Assess Safety and Tolerability in Patients With Chronic Spontaneous Urcaria (Part 1) and Food Effect in Healthy Adults (Part 2).","A Phase Ib Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Oral Doses of Alpha-0261 Tablets in Patients With Chronic Spontaneous Urticaria, and the Effect of Food in Healthy Participants.","Inclusion Criteria:\n\n* Written informed consent must be obtained before any assessment is performed.(Part 1 and Part 2)\n* Aged ≥ 18 and ≤ 75, male or female (Part 1).\n* Diagnosed with CSU prior to screening at least 6 months. (Part 1)\n* Received stable second-generation H1 antihistamine therapy for at least 2 weeks before randomization, and is willing to maintain the stable treatment regimen throughout the study treatment period. (Part 1)\n* Aged ≥ 18 and ≤ 55, male or female (Part 2).\n* Weight: ≥ 50 kg for males, ≥ 45 kg for females; 19 kg\u002Fm2 ≤ body mass index (BMI) ≤ 28 kg\u002Fm2. (Part 2)\n* In general good health. (Part 2)\n\nExclusion Criteria:\n\n* Inducible urticaria with identifiable triggers, including dermographism, cold contact urticaria, heat contact urticaria, solar urticaria, pressure urticaria, delayed pressure urticaria, aquagenic urticaria, cholinergic urticaria, or contact urticaria. (Part 1)\n* Other chronic pruritic skin diseases that may affect the assessment of study outcomes, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus, or psoriasis. (Part 1)\n* Other conditions that may cause urticaria or angioedema symptoms, including but not limited to urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria, or acquired\u002Fdrug-induced urticaria. (Part 1)\n* Have a history of any severe allergic reaction or anaphylaxis. (Part 2)\n* Any condition, which in the investigator's opinion might jeopardize articipant's safety or compliance with the protocol. (Part 2)\n* Have clinically significant abnormalities on clinical laboratory results. (Part 2)",true,"ALL","18 Years","75 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a randomized, double-blind, placebo-controlled phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of Alpha-0261 Tablets in healthy Chinese adults and in patients with chronic spontaneous urticaria.",[28,29],"Chronic Spontaneous Urticaria (CSU)","Healthy Volunteers","NOT_YET_RECRUITING","2026-06-28",{"date":33,"type":34},"2026-07-06","ACTUAL",{"date":36,"type":22},"2026-07-01",{"date":38,"type":22},"2027-06-30",{"name":40,"class":41},"AlphaMol Science Ltd. (Shanghai)","INDUSTRY",""]