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.

NCT06466525 | Recruiting Phase 1 DMC

• 1 other identifier: LBT-3627-101
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Incidence, nature, and severity of adverse events [Safety and Tolerability]

  Day of treatment to end of follow-up period (1, 2 or 4 weeks)

Secondary Outcomes (8)

• Maximum Plasma Concentration [Cmax]

  Day of treatment to end of follow-up period (1, 2 or 4 weeks)

• Elimination half life [T1/2]

  Day of treatment to end of follow-up period (1, 2 or 4 weeks)

• Time to reach Cmax [Tmax]

  Day of treatment to end of follow-up period (1, 2 or 4 weeks)

• Volume of Distribution [Vd]

  Day of treatment to end of follow-up period (1, 2 or 4 weeks)

• Concentration [C]

  Day of treatment to end of follow-up period (1, 2 or 4 weeks)

Study Arms (3)

Healthy Volunteers - SAD

EXPERIMENTAL

Single dose of LBT-3627 administered to healthy volunteers

Drug: LBT-3627; Drug: Placebo

Parkinson's disease patients - SAD

EXPERIMENTAL

Single dose of LBT-3627 administered to Parkinson's disease patients

Drug: LBT-3627; Drug: Placebo

Parkinson's disease patients - MAD

EXPERIMENTAL

Multiple doses of LBT-3627 administered to Parkinson's disease patients

Drug: LBT-3627; Drug: Placebo

Interventions

LBT-3627 DRUG

Synthetic peptide

Healthy Volunteers - SAD; Parkinson's disease patients - MAD; Parkinson's disease patients - SAD

Placebo DRUG

Vehicle

Healthy Volunteers - SAD; Parkinson's disease patients - MAD; Parkinson's disease patients - SAD

Eligibility Criteria

• Age: 30 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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.

Sponsors & Collaborators

• Longevity Biotech Australia Pty Ltd (subsidiary): lead

Study Sites (3)

Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Monash Medical Center

Melbourne, Victoria, 3168, Australia

RECRUITING

Nucleus Networks

Melbourne, Victoria, Australia

ACTIVE NOT RECRUITING

Related Links

• Michael J. Fox Trial Finder
• Shake It Up Trial Overview
• Alfred Health Clinical Trial Details

MeSH Terms

Conditions

Parkinson Disease

Interventions

LBT-3627

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Kelly Bertram, MD

CONTACT

+61 0487 531 448; k.bertram@alfred.org.au

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo controlled, double blind (patient and investigator)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo controlled, double blind, SAD and MAD dose escalation

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 20, 2024
• Study Start: July 16, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3)