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: 2

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:

• Participants will be included in the study only if they satisfy all the following criteria:
• Must have given written informed consent, before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.
• Healthy male or female, aged between 30 and 89 years, inclusive at screening.
• Body mass index (BMI) of 18 to 32 kg/m2, inclusive.
• Physical examination without any additional clinically relevant findings
• Systolic blood pressure in the range of 90 to 140 mmHg (inclusive) and diastolic blood pressure in the range of 40 to 90 (inclusive) mmHg after 5 minutes in supine/semi-supine, and subsequently after 3 minutes of standing position.
• Note 1: Participants with orthostatic hypotension are not permitted. Orthostatic hypotension is defined as ≥ 20 mm Hg reduction in systolic blood pressure and/or ≥ 10 mm Hg reduction in diastolic blood pressure between supine/semi-supine versus subsequent standing measurements.
• Note 2 (For Parkinson's Patients): If systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg, one repeat supine/semi-supine assessment is permitted within 5-10 minutes later, at the discretion of the PI (or delegate).
• Heart rate in the range of 50 to 100 beats/minute after 5 minutes rest in supine/semi-supine position, and subsequently after 3 minutes of standing position.
• Note: Participants with orthostatic hypotension are not permitted. Orthostatic hypotension is defined as ≥ 30 beats/minute increase in heart rate between supine/semi-supine versus subsequent standing measurements.
• \. Body temperature (tympanic), between 35.5°C and 37.5°C. 8. Electrocardiogram (ECG) without clinically significant abnormal including QT interval corrected for Fredericia (QTcF) \< 450 msec for male participants and \< 470 msec for female participants.
• \. No clinically significant findings in serum chemistry, haematology, coagulation or urinalysis (in the opinion of the Investigator).
• \. Female participants must be of non-child-bearing potential i.e., surgically sterilised (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 weeks before the screening visit) or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone \[FSH\] level consistent with postmenopausal status, per local laboratory guidelines), or, if of child-bearing potential:
• Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on Day -1, prior to dose administration.
• Must agree not to donate ova or attempt to become pregnant from the time of signing consent until at least 30 days after the last dose of study drug.

You may not qualify if:

• Participants will be excluded from the study if there is evidence of any of the following:
• Use of immunomodulators (including steroids and topical/oral/inhaled OTC glucocorticoids) within the past 60 days prior to the start of the first dose of study drug, unless approval is given by the study Sponsor (to be assessed at screening and Day -1)
• Use of coenzyme Q10 within 5 days prior to the start of the first dose of study drug. (to be assessed at screening and Day -1)
• Received a vaccine within 60 days of first dose of study drug (to be assessed at screening and Day -1)
• History of hypersensitivity reaction, anaphylaxis or other clinically significant reactions or known allergy to any of the study drug ingredients.
• History of transient ischemic attack or stroke or any unexplained loss of consciousness within 12 months of screening
• Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection upon admission to clinic on Day -1 (SARS-CoV-2 testing to be performed according to site standard process) or participant report of 'Long-COVID' any time prior to screening (where long-COVID is defined by probable or confirmed SARS-CoV-2 infection; usually within 3 months from the onset of COVID-19, with symptoms and effects that last for at least 2 months).
• History of any clinically significant disorder (which, in the opinion of the Investigator \[or delegate\] would make implementation of the protocol or interpretation of study results difficult, or that would put the participant at risk by participating in the study), including cardiovascular (including but not limited to unstable angina, myocardial infarction, chronic heart failure), hematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue, uncontrolled endocrine/metabolic, oncologic (within the last 5 years excluding basal cell or squamous epithelial carcinomas of the skin that have been resected with clear margins and with no evidence of recurrence for at least 12 months), neurologic (including seizures, strokes, brain tumours), and psychiatric (including but not limited to major depression, schizophrenia, bipolar disorder, personality, or substance abuse disorder), or any disorder that may prevent the successful completion of the study or influence the absorption, distribution, metabolism, excretion, or action of the study drug.
• Note: Participants with well-controlled asthma (and is not receiving inhaled or oral steroids) is permitted, per PI (or delegate) discretion. Participants with well controlled, mild depression or anxiety, with no change in medication within the past 3 months is permitted, per PI (or delegate) discretion.
• History of surgery or hospitalisation within 12 weeks prior to screening, or surgery planned during the study.
• Lack of suitable veins for multiple venepunctures/cannulations as assessed by the Investigator or delegate at screening.
• Presence of any tattoos or scarring which (in the opinion of the Investigator \[or delegate\]) would interfere with injection site reaction assessments.
• Laboratory results at screening that indicate inadequate renal function (estimated creatinine clearance (CrCl) \< 60mL/min (if either healthy and aged 40 and above or a Parkinson's patient) or \< 79mL/min (if healthy and under 40 years)using the Cockcroft Gault formula).
• Liver function test results elevated more than 1.5-fold above the ULN for gamma glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate aminotransferase (AST) or alanine aminotransferase (ALT). Volunteers with ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs and are determined to be normal variants.
• Liver function tests outside the normal range for bilirubin (more than 1.5-fold above the ULN for total bilirubin).

Sponsors & Collaborators

• Longevity Biotech Australia Pty Ltd (subsidiary): lead

Study Sites (2)

Alfred Hospital

Melbourne, Victoria, Australia

RECRUITING

Nucleus Networks

Melbourne, Victoria, Australia

ACTIVE NOT RECRUITING

Related Links

• Michael J. Fox Trial Finder
• Shake It Up Trial Overview

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

Tim Porter, MBBS, FANZCA, MBioethics

CONTACT

+61 450992172; Tim.Porter@avancecro.com

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: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)