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
This is a randomized, placebo-controlled, single ascending dose (SAD) study of SER-252 in participants with Parkinson's Disease (PD) and motor fluctuations.
• Female or male participants 40-80 years of age, inclusive, at the time of screening
• 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
• 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
• Routine early-morning OFF, corroborated by investigator interview at Screening
• Presence of a total daily OFF time duration of ≥2 hours during the waking day based on participant self-assessment and Investigator's judgment
• \*Hoehn and Yahr scale ≤ 3 in the ON state during screening (\*part of the MDS- UPDRS Part III assessment)
• Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont)
• Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort
• Montreal Cognitive Assessment ≥ 24
⁃ Women of child-bearing potential (WOCBP) who are sexually active with a male partner must use a reliable method of contraception from the time of consent through at least 3 months after the last dose of study medication. Reliable methods of contraception include oral contraceptive or long-term injectable or implantable hormonal contraceptive, or intra-uterine devices when used in combination with male condoms, and must have a negative serum pregnancy test at Screening and negative urine pregnancy test at baseline. Males who are sexually active and whose partners are females of childbearing potential must agree to use male condoms from the time of consent through 3 months after administration of the last dose of study drug, and their partners must be willing to use a highly effective method of contraception from screening through 3 months after administration of the last dose of study drug.
⁃ Willing and able to comply with all study activities and requirements, including safety follow-up
⁃ Provide written informed consent
⁃ Approved by a central Enrollment Authorization Committee (EAC)