RESEARCH / PARTICIPATIONBack to the library
← Find a study
Recruiting · registry status

Early safety testing of LBT-3627

Researchers test increasing doses of the study medicine LBT-3627 in volunteers with and without Parkinson’s, checking safety and how well people tolerate it.

Testing a treatment or activity · Study reference: NCT06466525

Plain-language introduction written with AI from the registry; not independently checked by a clinician. Read the original details below ↓

Open the official registry record ↗

Who can join?

Ages 30 years to 89 years · Also accepts healthy volunteers

These are starting points, not the full rules. The research team can tell you whether the study is right for your situation.

Read all the rules for taking part

Sex eligibility reported by registry: all

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.
Full study name & original research details

Official study 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.

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.

Further description from the registry

Evaluate the safety and tolerability of LBT-3627 in both a single and multiple ascending dose study. Phase Ia will explore safety and tolerability first in healthy volunteers then followed by Parkinson's patients after a single dose. Dose levels will escalate per cohort. Phase Ib will explore safety and tolerability in Parkinson's patients after multiple doses. Dose levels will escalate per cohort.

Conditions reported: Parkinson Disease

Study type
Interventional
Interventions
LBT-3627; Placebo
Phases
PHASE1
Sponsor
Longevity Biotech Australia Pty Ltd (subsidiary)
Start date reported by registry
2024-07-16 (actual)

Registry updated: 2026-09-25 · Status last verified by the registry submitter: 2026-09

Registry records retrieved 2026-10-11 (UTC). Individual records may have older updates. Recruitment and eligibility must be confirmed with the study team.

Contact the research team

Public study contacts supplied to the registry. Ask whether recruitment is still open and what participation involves.

Kelly Bertram, MD · +61 0487 531 448 · k.bertram@alfred.org.au

Study locations

Site status can differ from overall study status. “Status not reported” means local availability needs confirmation. Remote participation and travel arrangements must be checked with the team.

Alfred Hospital

Melbourne, Victoria, Australia

Recruiting

Beth Sutherland · +61 0487 531 448 · B.Sutherland@alfred.org.au

Monash Medical Center

Melbourne, Victoria, Australia

Recruiting

May Ho · +61 03 9594 3051 · wing.ho@monashhealth.org

Nucleus Networks

Melbourne, Victoria, Australia

Active not recruiting

The original descriptions and participation rules come from the registry. Participation is voluntary and does not guarantee benefit.