RecruitingPhase 1NCT07422675

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations

A Randomized, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety, Tolerability, and Pharmacokinetics of SER-252 in Patients With Parkinson's Disease and Motor Fluctuations

Sponsor

Serina Therapeutics

Enrollment

40 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

PARKINSON DISEASE (Disorder)Advanced Parkinson's Disease

Summary

This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug for people with Parkinson's disease who experience "off" periods — times during the day when their medication stops working as well and their movement symptoms (stiffness, slowness, tremor) return. These are called motor fluctuations, and they are a common challenge with long-term levodopa treatment. **You may be eligible if...** - You are 40 to 80 years old - You have a confirmed diagnosis of idiopathic Parkinson's disease - You have clear motor fluctuations ("on/off" periods) during the day - You are on a stable Parkinson's medication regimen **You may NOT be eligible if...** - Your Parkinson's symptoms are not clearly responsive to levodopa - You have atypical Parkinson's or other neurological conditions - Your medication regimen is not stable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSER-252 (PEOZ-apomorphine)

SER-252 drug product consists of 20mg lyophilized apomorphine equivalent in SER-252 drug substance in a sterile vial for reconstitution with a diluent product containing 15mM acetate buffer at pH 6.0 and 7% trehalose to maintain final pH and isotonicity in the reconstituted product.

DEVICEenFuse

The enFuse® device is a sterile, non-pyrogenic, user-filled, single-use, fixed-dose subcutaneous dose delivery system.