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.
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
Study identifier: NCT06466525. Status: RECRUITING. Phase: PHASE1.
Eligibility
Criteria: Both cohorts (Healthy Volunteers and Parkinson's Disease) Key inclusion criteria * Male or female, 30-89 years inclusive at screening * BMI 18-32 kg/m² * Vital signs, ECG (QTcF \<450 ms male / \<470 ms female), and safety labs without clinically significant abnormality; no orthostatic hypotension * Women of non-childbearing potential, or using highly effective contraception per protocol Key exclusion criteria * Immunomodulators / steroids - HV: any (incl. OTC) within 90 days; PD: systemic within 60 days and topical/nasal-inhaled OTC within 7 days (both waivable only with Sponsor approval) * Vaccine within 60 days (HV) / 45 days (PD) of first dose * CoQ10 within 5 days * Inadequate renal function (CrCl ≤ 60 mL/min; ≤ 79 if HV under 40), or LFTs / bilirubin \> 1.5× ULN * Clinically significant cardiovascular, hepatic, renal, neurological, or psychiatric disease * Active infection requiring systemic anti-infectives within 14 days; positive HBV/HCV/HIV serology Parkinson's Disease participants - additional key inclusion criteria * PD diagnosis by a neurologist/geriatrician, 6 months to \< 11 years before first dose, per MDS clinical diagnostic criteria * Hoehn \& Yahr stage 1-3 * If on levodopa: stable ≥ 2 months and able to withhold ≥ 12 hours (overnight) around dosing/assessments; if not, remain treatment-naïve through end of study Parkinson's Disease participants - additional key exclusion criteria * Prior PD brain surgery, focused ultrasound, or neuromodulation; no anti-amyloid/anti-tau biologics * Antibiotics within 30 days; OTC pre/probiotics; ≥ 3 unexplained falls in 12 months Note: Additional protocol-defined criteria apply.
- Minimum age: 30 Years
- Maximum age: 89 Years
Participating locations
- Alfred Hospital, Melbourne, Victoria
- Monash Medical Center, Melbourne, Victoria
- Nucleus Networks, Melbourne, Victoria
Study records are sourced from ClinicalTrials.gov. Confirm current eligibility, recruiting status, and locations in the official record.