Could a synthetic peptide offer a new way to tackle Parkinson's?
NCT ID NCT06466525
This trial is taking on new participants right now.
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
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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
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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Alfred Hospital
RECRUITINGMelbourne, Victoria, Australia
Contact Email: •••••@•••••
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Nucleus Networks
ACTIVE_NOT_RECRUITINGMelbourne, Victoria, Australia
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