[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551933":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":65,"collaborators":29,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":29,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":29,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":29,"overallStatus":43,"whyStopped":29,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":96},{"fullName":5,"class":6},"Longevity Biotech","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Healthy Volunteers - SAD","EXPERIMENTAL","Single dose of LBT-3627 administered to healthy volunteers",[13,14],"Drug: LBT-3627","Drug: Placebo",{"label":16,"type":10,"description":17,"interventionNames":18},"Parkinson's disease patients - SAD","Single dose of LBT-3627 administered to Parkinson's disease patients",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Parkinson's disease patients - MAD","Multiple doses of LBT-3627 administered to Parkinson's disease patients",[13,14],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","LBT-3627","Synthetic peptide",[9,20,16],null,{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Placebo","Vehicle",[9,20,16],[35],{"name":36,"role":37,"phone":38,"phoneExt":29,"email":39},"Tim Porter, MBBS, FANZCA, MBioethics","CONTACT","+61 450992172","Tim.Porter@avancecro.com",[41,59],{"facility":42,"status":43,"city":44,"state":45,"zip":29,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Alfred Hospital","RECRUITING","Melbourne","Victoria","Australia","AU",{"type":49,"coordinates":50},"Point",[51,52],144.96332,-37.814,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":29,"email":58},"Jack Germaine","+61 487 531 448","NeurologyClinicaltrials@alfred.org.au",{"facility":60,"status":61,"city":44,"state":45,"zip":29,"country":46,"countryCode":47,"cosmosGeoPoint":62,"geoPoint":64,"contacts":29},"Nucleus Networks","ACTIVE_NOT_RECRUITING",{"type":49,"coordinates":63},[51,52],{"lat":52,"lon":51},{"type":66,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","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":78,"type":79},64,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","Phase I a\u002Fb SAD\u002FMAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.",[85],"Parkinson Disease","2026-08-20",{"date":88,"type":89},"2026-08-21","ACTUAL",{"date":91,"type":89},"2024-07-16",{"date":93,"type":79},"2027-02",{"name":95,"class":6},"Longevity Biotech Australia Pty Ltd (subsidiary)",2]