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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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.

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) is a Phase 1 interventional studying Parkinson Disease, sponsored by Longevity Biotech Australia Pty Ltd (subsidiary). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Parkinson Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 64 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Parkinson Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Inclusion Criteria (Everyone) Participants will be included in the study only if they satisfy all the following criteria: 1. Must have given written willing to sign a consent form, 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. 2. Healthy male or female, aged between 30 and 89 years, inclusive at screening. 3. Body mass index (BMI) of 18 to 32 kg/m2, inclusive. 4. Physical examination without any additional clinically relevant findings 5. 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). 6. 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. 7\. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria (Everyone) Participants will be included in the study only if they satisfy all the following criteria: 1. 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. 2. Healthy male or female, aged between 30 and 89 years, inclusive at screening. 3. Body mass index (BMI) of 18 to 32 kg/m2, inclusive. 4. Physical examination without any additional clinically relevant findings 5. 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). 6. 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. 7\. 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. 9\. No clinically significant findings in serum chemistry, haematology, coagulation or urinalysis (in the opinion of the Investigator). 10\. 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: 1. Must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test on Day -1, prior to dose administration. 2. 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. 3. If not exclusively in a same-sex relationship, must agree to remain abstinent throughout the study, or must agree to use adequate contraception (which is defined as use of a condom by the male partner combined with use of a highly effective method of contraception from one month prior to screening until at least 30 days after the last dose of study drug. 11\. Male participants must: 1. Agree not to donate sperm from the time of signing consent until at least 30 days after the last dose of study drug. 2. If engaging in sexual intercourse with a female partner who could become pregnant, agree to use adequate contraception (defined as use of a condom plus a highly effective method of contraception from the time of signing consent until at least 30 days after the last dose of study drug. 3. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, agree to use a condom from the time of signing consent until at least 30 days after the last dose of study drug. 12\. Willing and able to comply with all scheduled visits, treatment plans, laboratory tests and other study procedures. Exclusion Criteria (Everyone) Participants will be excluded from the study if there is evidence of any of the following: 1. 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) 2. 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) 3. Received a vaccine within 60 days of first dose of study drug (to be assessed at screening and Day -1) 4. History of hypersensitivity reaction, anaphylaxis or other clinically significant reactions or known allergy to any of the study drug ingredients. 5. History of transient ischemic attack or stroke or any unexplained loss of consciousness within 12 months of screening 6. 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). 7. 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. 8. History of surgery or hospitalisation within 12 weeks prior to screening, or surgery planned during the study. 9. Lack of suitable veins for multiple venepunctures/cannulations as assessed by the Investigator or delegate at screening. 10. Presence of any tattoos or scarring which (in the opinion of the Investigator \[or delegate\]) would interfere with injection site reaction assessments. 11. 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). 12. 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. 13. Liver function tests outside the normal range for bilirubin (more than 1.5-fold above the ULN for total bilirubin). 14. Any clinically relevant laboratory finding or medical condition that could place the volunteer at risk for participation in the study. 15. Any active infection requiring systemic antibiotic, antifungal, or antiviral medication within 14 days prior to first dose of study drug (to be confirmed at screening and Day 1). 16. Concurrent enrolment in another clinical study, or participation in another clinical study within 90 days prior to screening. 17. Regular consumption of \>10 standard alcoholic drinks/week where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer \[4.9% Alc/Vol\], 100 mL wine \[12% Alc/Vol\], 30 mL spirit \[40% Alc/Vol\]). 18. Positive alcohol breath or plasma test at screening or upon admission to the clinic on Day -1. 19. Positive urine drugs of abuse test at screening or upon admission to the clinic on Day -1. 20. Participant has a positive cotinine test upon admission to the clinic on Day -1. 21. Participant smokes more than 5 cigarettes or equivalent per week, and/or participant is unwilling to abstain from smoking for 72 hours prior to check-in on Day -1 and throughout the confinement period at the study site. 22. Use of cannabis or delta-9- tetrahydrocannabinol (THC), including for medicinal purposes, within 90 days prior to the start of the first dose of study drug, and/or participant is unwilling to abstain from use during the study 23. Participant is breastfeeding or pregnant, or planning to breastfeed or become pregnant during the study. 24. Known substance abuse or medical, psychological, or social conditions that, in the opinion of the PI (or delegate), may interfere with the participants inclusion in the clinical study or evaluation of the clinical study results. 25. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C (HepC) virus antibody, or human immunodeficiency (HIV) antibody tests at screening. 26. Participant has donated blood/blood products, experienced significant (\> 500 mL) blood loss within 3 months prior to the first dose administration or receipt of a blood transfusion within 1 year prior to the first dose administration. 27. Any other condition or prior therapy that in the opinion of the Investigator (or delegate) would make the participant unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements. Additional Inclusion Criteria (Parkinson's Disease Participants) Parkinson's Disease Participants will be included in the study only if they satisfy all the following criteria: 1. Diagnosis of Parkinson's disease as defined by: • Evidence (written confirmation by a neurologist or geriatrician) of diagnosis of Parkinson's disease between 1-10 years prior to first dose administration. Note: Criteria for diagnosis of Parkinson's disease is per the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease: * Progressive asymmetric onset of bradykinesia * Muscle rigidity and/or rest tremor (4- to 6-Hz tremor in the fully resting limb) o Hoehn and Yahr score of 1-3 (inclusive) o Not diagnosed with any other neurodegenerative diseases. o If on levodopa containing medications: Stable levodopa containing medications for at least 2 months prior to screening with ability to be withdrawn from therapy for at least 12 hours (e.g., overnight) prior to study drug administration and on-study assessments. Participants will be able to resume therapy immediately after study drug is administrated and on-study assessments are completed. * If not on levodopa containing medications: To be able to remain treatment naïve throughout the study from screening through to the final EoS visit. Additional Exclusion Criteria (Parkinson's Disease Participants) Parkinson's Disease Participants will be excluded from the study if there is evidence of any of the following: 1\. Use of antibiotics within 30 days prior to the start of the first dose of study drug (to be assessed at screening and Day -1). 2\. Use of over-the-counter (OTC) prebiotics and probiotics supplements. Note: Participants receiving stable use of within 30 days prior to the start of the first dose of study drug may be permitted. (to be assessed at screening and Day -1). 3\. History of use of any biologic therapy targeting beta-amyloid peptides or tau protein. 4\. History of any brain surgery for Parkinson's disease, or a history of focused ultrasound treatment at any time, or history of any neuromodulation procedures. 5\. Unexplained falls (≥ 3 falls) within 12 months prior to the start of the first dose of study drug. 6\. History of in situ prostate carcinoma. 7. History of any concomitant disease, including cardiovascular (including but not limited to unstable angina, myocardial infarction, chronic heart failure), hematologic, pulmonary, hepatic, renal, gastrointestinal, connective tissue, uncontrolled endocrine/metabolic, neurologic (including seizures, strokes, brain tumours; but not including Parkinson's disease), 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 1: Participants with diagnosed concomitant diseases that are considered stable by the PI for \> 6 months (including those receiving stable concomitant therapy) may be permitted if agreed in consultation with the Sponsor. Note 2: Participants with well-controlled asthma (and are not receiving inhaled or oral steroids) are permitted, per PI (or delegate) discretion. 1. Any history of cancer 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). 2. History of non-elective and/or non-routine surgery or hospitalisation within 12 weeks prior to screening, or surgery planned during the study, at the discretion of the PI.

Treatments Being Tested

DRUG

LBT-3627

Synthetic peptide

DRUG

Placebo

Vehicle

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Alfred Hospital
Melbourne, Victoria, Australia
Nucleus Networks
Melbourne, Victoria, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06466525), the sponsor (Longevity Biotech Australia Pty Ltd (subsidiary)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06466525 clinical trial studying?

Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06466525?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06466525?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06466525. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06466525. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.