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
Serina Therapeutics
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.
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 asse…
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria 1. Female or male participants 40-80 years of age, inclusive, at the time of screening 2. Diagnosis of idiopathic Parkinson's disease consistent with UK Brain Bank and MDS Research Criteria; must include bradykinesia with sequence effect, motor asymmetry if no rest tremor, and a reliable, visible response to levodopa 3. On a stable regimen of anti-Parkinsonian medication for at least 4 weeks prior to Screening; MAOBIs must be stable for at least 12 weeks prior to Screening 4. Routine early-morning OFF, corroborated by investigator interview at Screening 5. Presence of a tot…
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.
Locations (6)
- Rocky Mountain Clinical ResearchEnglewood, Colorado
- Velocity Clinical ResearchHallandale, Florida
- K2 Medical Research LLCMaitland, Florida
- Quest Research InstituteFarmington Hills, Michigan
- CMAXAdelaide, South Australia
- MonashMelbourne, Victoria