[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606885":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":40,"centralContacts":40,"locations":41,"responsibleParty":70,"collaborators":40,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":40,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":96,"overallStatus":44,"whyStopped":40,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Granular Therapeutics Limited","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A (HV) - GTX-B001","EXPERIMENTAL","Healthy participants will receive a single dose of GTX-B001",[13],"Drug: GTX-B001",{"label":15,"type":16,"description":17,"interventionNames":18},"Part A (HV) - Normal Saline","PLACEBO_COMPARATOR","Healthy participants assigned to receive placebo will receive a single dose of normal saline",[19],"Drug: Normal Saline",{"label":21,"type":10,"description":22,"interventionNames":23},"Part B (ColdU\u002FSD) - GTX-B001","Patients with cold urticaria or symptomatic dermographism will receive a single dose of GTX-B001",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"Part B (ColdU\u002FSD) - Normal Saline","Patients with cold urticaria or symptomatic dermographism assigned to receive placebo will receive a single dose of normal saline",[19],[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","GTX-B001","Single infusion of one of up to five dosages of GTX-B001",[9,21],[35],"ALY-301",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Normal Saline","Single infusion of normal saline",[15,25],null,[42,60],{"facility":43,"status":44,"city":45,"state":40,"zip":40,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Charité Research Organization gmbh","RECRUITING","Berlin","Germany","DE",{"type":49,"coordinates":50},"Point",[51,52],13.41053,52.52437,{"lat":52,"lon":51},[55],{"name":56,"role":57,"phone":58,"phoneExt":40,"email":59},"Principal Investigator","CONTACT","+49 30 450 539 200","info@charite-research.org",{"facility":61,"status":62,"city":45,"state":40,"zip":40,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Fraunhofer Institute For Translational Medicine And Pharmacology","NOT_YET_RECRUITING",{"type":49,"coordinates":64},[51,52],{"lat":52,"lon":51},[67],{"name":56,"role":57,"phone":68,"phoneExt":40,"email":69},"+49 30 450 518 219","study-coordination-berlin@itmp.fraunhofer.de",{"type":71,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100606885","phase-1-a-phase-1-study-of-gtx-b001-in-healthy-subjects-and-patients-with-chronic-inducible-urticaria-100606885",false,"NCT07181369","A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Tolerability, Pharmacokinetic, Pharmacodynamic, and Preliminary Efficacy Trial of GTX-B001 in Healthy Volunteers (Part A) and Patients With Chronic Inducible Urticaria (Part B)","CHILL-MC","Key inclusion Criteria (Part A):\n\n* The subject is between 18 and 55 years of age (both inclusive) at the date of screening.\n* The subject is in good general health based on the medical history, physical examination and the results of vital signs, electrocardiogram and clinical laboratory, as judged by the investigator.\n\nKey inclusion Criteria (Part B):\n\n* The subject is between 18 and 75 years of age (both inclusive) at the date of screening\n* A history of signs and\u002For symptoms of ColdU or SD experienced ≥ 3 months prior to screening.\n* For ColdU patients, a positive provocation test during screening and baseline, using the TempTest® device.\n* For SD patients, a positive provocation test with at least 3 pins during screening and baseline, using the FricTest® device.\n* Inadequate control of ColdU or SD by second generation H1-antihistamine (sgAH) as defined as the presence of itch and hives following a trigger (e.g. cold or scratching, respectively) within the last 6 weeks prior to screening in spite of use of a sgAH.\n* A Urticaria Control Test (UCT) score of \\\u003C 12 at screening.\n\nKey exclusion Criteria (Parts A \\& B):\n\n* Presence of any clinically significant illness, such as cardiovascular, neurologic, pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine disease or disorder that would interfere with the patient's safety or the interpretation of trial results in the judgment of the investigator.\n* Treatment with an investigational drug or intervention for any condition within three months of screening, or concurrent participation in another clinical trial in which an investigational drug is administered.\n* Treatment with immunomodulating therapy (e.g., intravenous or intramuscular immunoglobulins, systemic corticosteroids, cyclosporine, methotrexate, dapsone, cyclophosphamide, tacrolimus, mycophenolate mofetil, hydroxychloroquine, infliximab, adalimumab, etanercept, etc.) within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.\n* Use of any monoclonal antibody or therapeutic protein within 4 weeks (or 5 half-lives, whichever is longer) prior to screening.\n* History of anaphylaxis, autoimmune disorders requiring more than topical medication, or asthma requiring regular use of inhaled medication within the past 5 years, unless, in the opinion of the Investigator, the condition is not considered clinically significant and is unlikely to affect subject safety or study outcomes.\n\nAdditionally for Part B:\n\n* Disease with symptoms of urticaria or angioedema other than Chronic Urticaria (CU), for example urticaria vasculitis, erythema multiforme, mastocytosis, or drug-induced urticaria. Patients with concomitant Chronic Spontaneous Urticaria (CSU) or other forms of Chronic Inducible Urticaria (CIndU) are eligible provided that symptoms at screening are consistent with ColdU or SD and that ColdU or SD is the dominant form of CU.\n* Any other skin disease associated with chronic itching that might influence in the investigators' opinion of the study evaluations and results, e.g., atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, or psoriasis.\n* Receipt of any biologic therapy for urticaria control (e.g. omalizumab, dupilumab, ligelizumab, etc.) within three months of screening (whether on-label or off-label).",true,"ALL","18 Years","75 Years",{"count":85,"type":86},72,"ESTIMATED","INTERVENTIONAL",[89],"PHASE1","This is a first-in-human study aimed at determining the safety of a single dose of GTX-B001 in healthy participants and in people with chronic inducible urticaria.",[92,93,94,95],"Healthy Subjects","Cold Urticaria","Symptomatic Dermographism","Chronic Inducible Urticaria",[97,98,99,100,31,101,102,103,104,105,106,107,108,109],"Urticaria","Skin diseases","Mast cells","Bispecific antibody","Infusion","Single Ascending Dose","Healthy subjects","Safety","Pharmacokinetics","Pharmacodynamics","Cold urticaria","Intravenous","symptomatic dermographism","2026-01-28",{"date":112,"type":113},"2026-01-30","ACTUAL",{"date":115,"type":113},"2025-10-06",{"date":117,"type":86},"2027-08",{"name":5,"class":6},2]