NCT07422675

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Serina Therapeutics · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Participants will be enrolled into five sequential groups. Each group will include eight participants, dosed in a 3:1 ratio (six receiving SER-252 and two receiving placebo). All participants will receive a single dose of study drug. Each successive group will receive a higher dose level of SER-252 than the previous group. Some participants will receive a subcutaneous injection of SER-252, while others will receive placebo. Single ascending dose (SAD) cohorts will utilize a sentinel dosing approach, with subsequent dosing conducted in a staggered manner if ongoing safety and tolerability assessments allow. In each cohort, the first two participants (one receiving SER-252 and one receiving placebo) will be dosed separately ahead of the remaining participants. These sentinel participants will be observed and evaluated as described in the protocol before dosing proceeds for the rest of the cohort.

Conditions

• PARKINSON DISEASE (Disorder)
• Advanced Parkinson's Disease

Interventions

Type	Name	Description
DRUG	SER-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.
DEVICE	enFuse	The enFuse® device is a sterile, non-pyrogenic, user-filled, single-use, fixed-dose subcutaneous dose delivery system.

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2026-02-20
• Last updated: 2026-04-15

Locations

4 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study