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.
Recruiting · NCT06466525 · Interventional (participants receive a specific treatment) · Lead sponsor: Longevity Biotech Australia Pty Ltd (subsidiary)
View the official record on ClinicalTrials.gov →Interventions studied
LBT-3627Placebo
What this trial is about
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
Who can take part
Age range
30 Years to 89 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed.
- Alfred Hospital - Melbourne, Victoria, Australia
- Nucleus Networks - Melbourne, Victoria, Australia