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Could a synthetic peptide offer a new way to tackle Parkinson's?

NCT ID NCT06466525

Disease control Sponsor: Longevity Biotech Australia Pty Ltd (subsidiary) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This early-stage trial evaluates the safety and tolerability of an investigational drug called LBT-3627, a synthetic peptide, in healthy adults and in people with Parkinson's disease. Participants receive either the drug or a placebo, and researchers monitor side effects and how the drug moves through the body. The goal is to determine if LBT-3627 is safe enough to study further as a potential treatment for Parkinson's.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LBT-3627, a synthetic peptide
What this could lead to
If safe and well-tolerated, LBT-3627 could become a new treatment option to help manage Parkinson's disease symptoms.
What could go wrong
This is an early Phase 1 trial focused on safety, not effectiveness. The drug may not work as hoped or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 89 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alfred Hospital

    RECRUITING

    Melbourne, Victoria, Australia

    Contact Email: •••••@•••••

  • Nucleus Networks

    ACTIVE_NOT_RECRUITING

    Melbourne, Victoria, Australia

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