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Taking people in AustraliaPhase 1

Tests LBT-3627 safety in healthy people and people with Parkinson's disease

Checks whether the drug LBT-3627 is safe, with healthy people and people with Parkinson's.

Plain-language title generated from the registry record
Registry title: 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.

Key facts

Where
Melbourne, AustraliaSee the 3 sites
Phase
Phase 1

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 30 and 89 years old?

Source: NCT06466525, who can take part

Where in Australia

  • Alfred HospitalMelbourne, AustraliaTaking people
  • Monash Medical CenterMelbourne, AustraliaTaking people
  • Nucleus NetworksMelbourne, AustraliaNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Longevity Biotech Australia Pty Ltd (subsidiary)
Trial code
NCT06466525
Record updated
25 September 2026
Original description
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: 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; Prior PD brain surgery, focused ultrasound, or neuromodulation; no anti-amyloid/anti-tau biologics; 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; 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; Inadequate renal function (CrCl ≤ 60 mL/min; ≤ 79 if HV under 40), or LFTs / bilirubin > 1.5× ULN; PD diagnosis by a neurologist/geriatrician, 6 months to < 11 years before first dose, per MDS clinical diagnostic criteria; CoQ10 within 5 days; Hoehn \& Yahr stage 1-3; Antibiotics within 30 days; OTC pre/probiotics; ≥ 3 unexplained falls in 12 months; Note: Additional protocol-defined criteria apply.

Both cohorts (Healthy Volunteers and Parkinson's Disease).

ClinicalTrials.gov NCT06466525