[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634500":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":30,"locations":36,"responsibleParty":52,"collaborators":29,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":29,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":29,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":78,"whyStopped":29,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"GH Research Ireland Limited","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"GH001","EXPERIMENTAL","A single inhaled dose of GH001 administered via a proprietary aerosol delivery device in 12 subjects",[13,14],"Drug: 5 Methoxy N,N Dimethyltryptamine","Device: GH001 Aerosol Delivery System",[16,24],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","5 Methoxy N,N Dimethyltryptamine","GH001 administered via inhalation",[9],[22,9,23],"Mebufotenin","5-MeO-DMT",{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","GH001 Aerosol Delivery System","GH001 aerosol delivery system",[9],null,[31],{"name":32,"role":33,"phone":34,"phoneExt":29,"email":35},"GH Research Limited Clinical Trial Enquiries","CONTACT","+353874503237","clinicaltrials@ghres.com",[37],{"facility":38,"status":29,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"GH Research Clinical Trial Site","Miami","Florida","33319","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-80.19366,25.77427,{"lat":48,"lon":47},[51],{"name":38,"role":33,"phone":29,"phoneExt":29,"email":29},{"type":53,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100634500","phase-1-pharmacokinetics-and-safety-of-gh001-delivered-via-a-gh001-aerosol-delivery-system-in-healthy-subjects-100634500",false,"NCT07540494","Pharmacokinetics and Safety of GH001 Delivered Via a GH001 Aerosol Delivery System in Healthy Subjects","An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics and Safety of GH001 Administered Via a GH001 Aerosol Delivery System in Healthy Subjects","Inclusion Criteria:\n\n* Body mass index (BMI) in the range of 18.5 to 35 kg\u002Fm2 (inclusive) at screening.\n* Good mental health in the opinion of the investigator.\n* Normal spirometry (FEV1 of \\>80% of predicted and FVC of \\>80% of predicted value) at screening.\n\nExclusion Criteria:\n\n* Has known allergies or hypersensitivity or any other contraindication to mebufotenin, bufotenin, melatonin or triptans.\n* Has received any investigational medication, including investigational vaccines, in the 90 days prior to baseline or is in the follow-up period of another clinical trial at the time of screening for this trial.\n* Has a current or past clinically significant condition, which renders the subject unsuitable for the trial according to the investigator's judgement.",true,"ALL","21 Years","64 Years",{"count":66,"type":67},12,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration.",[73],"Healthy Adult",[22,23,75,9,76,77],"5-methoxy-N,N-dimethyltryptamine","Healthy volunteers","Pharmacokinetics","NOT_YET_RECRUITING","2026-04-14",{"date":81,"type":82},"2026-04-20","ACTUAL",{"date":84,"type":67},"2026-04",{"date":86,"type":67},"2026-05",{"name":5,"class":6},1]