[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Longevity Biotech Australia Pty Ltd (subsidiary)\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"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":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100551933","phase-1-a-two-part-single-and-multiple-ascending-dose-trial-of-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-lbt-3627-in-healthy-participants-and-in-participants-with-parkinsons-disease-100551933",false,"NCT06466525","A Two-Part Single and Multiple Ascending Dose Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBT-3627 in Healthy Participants and in Participants With Parkinson's Disease.","Both cohorts (Healthy Volunteers and Parkinson's Disease)\n\nKey inclusion criteria\n\n* Male or female, 30-89 years inclusive at screening\n* BMI 18-32 kg\u002Fm²\n* Vital signs, ECG (QTcF \\\u003C450 ms male \u002F \\\u003C470 ms female), and safety labs without clinically significant abnormality; no orthostatic hypotension\n* Women of non-childbearing potential, or using highly effective contraception per protocol\n\nKey exclusion criteria\n\n* Immunomodulators \u002F steroids - HV: any (incl. OTC) within 90 days; PD: systemic within 60 days and topical\u002Fnasal-inhaled OTC within 7 days (both waivable only with Sponsor approval)\n* Vaccine within 60 days (HV) \u002F 45 days (PD) of first dose\n* CoQ10 within 5 days\n* Inadequate renal function (CrCl ≤ 60 mL\u002Fmin; ≤ 79 if HV under 40), or LFTs \u002F bilirubin \\> 1.5× ULN\n* Clinically significant cardiovascular, hepatic, renal, neurological, or psychiatric disease\n* Active infection requiring systemic anti-infectives within 14 days; positive HBV\u002FHCV\u002FHIV serology\n\nParkinson's Disease participants - additional key inclusion criteria\n\n* PD diagnosis by a neurologist\u002Fgeriatrician, 6 months to \\\u003C 11 years before first dose, per MDS clinical diagnostic criteria\n* Hoehn \\& Yahr stage 1-3\n* If on levodopa: stable ≥ 2 months and able to withhold ≥ 12 hours (overnight) around dosing\u002Fassessments; if not, remain treatment-naïve through end of study\n\nParkinson's Disease participants - additional key exclusion criteria\n\n* Prior PD brain surgery, focused ultrasound, or neuromodulation; no anti-amyloid\u002Fanti-tau biologics\n* Antibiotics within 30 days; OTC pre\u002Fprobiotics; ≥ 3 unexplained falls in 12 months\n\nNote: Additional protocol-defined criteria apply.",true,"ALL","30 Years","89 Years",{"count":20,"type":21},64,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Phase I a\u002Fb SAD\u002FMAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.",[27],"Parkinson Disease","RECRUITING","2026-08-20",{"date":31,"type":32},"2026-08-21","ACTUAL",{"date":34,"type":32},"2024-07-16",{"date":36,"type":21},"2027-02",{"name":38,"class":39},"Longevity Biotech Australia Pty Ltd (subsidiary)","INDUSTRY",2,""]