[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GH Research Ireland Limited\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":73},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":21,"type":22},12,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28],"Healthy Adult",[30,31,32,33,34,35],"Mebufotenin","5-MeO-DMT","5-methoxy-N,N-dimethyltryptamine","GH001","Healthy volunteers","Pharmacokinetics","NOT_YET_RECRUITING","2026-04-14",{"date":39,"type":40},"2026-04-20","ACTUAL",{"date":42,"type":22},"2026-04",{"date":44,"type":22},"2026-05",{"name":46,"class":47},"GH Research Ireland Limited","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":16,"sex":17,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":48},"100555427","phase-1-pharmacokinetics-of-gh001-delivered-via-a-proprietary-aerosol-delivery-device-in-healthy-subjects-100555427","NCT06511947","Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects","An Open-label Phase 1 Trial to Determine the Pharmacokinetics, Pharmacodynamics, and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device 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 3 months 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.","18 Years",{"count":58,"type":22},52,[25],"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 and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK\u002F pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax\u002F2 and TCmax\u002F10 (time taken for Cmax to decrease by 50 and 90%, respectively) are also assessed.",[62],"Healthy Volunteers",[30,31,32,33,34,35],"RECRUITING","2024-08-06",{"date":67,"type":40},"2024-08-07",{"date":69,"type":40},"2024-08-01",{"date":71,"type":22},"2025-02",{"name":46,"class":47},""]