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SAD Study in Patients With Parkinson's Disease and Motor Fluctuations | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07422675•Serina Therapeutics

View on ClinicalTrials.gov

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.

Eligibility

Age

40 - 80 years

Sex

ALL

Healthy Volunteers

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 total daily OFF time duration of ≥2 hours during the waking day based on participant self-assessment and Investigator's judgment
•6. \*Hoehn and Yahr scale ≤ 3 in the ON state during screening (\*part of the MDS- UPDRS Part III assessment)
•7. Levodopa administration at least 4 times daily (immediate or extended release) or three times daily (Rytary or Crexont)
•8. Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort
•9. Montreal Cognitive Assessment ≥ 24
•10. 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.
+3 more criteria

Exclusion Criteria

•1. Diagnosis of secondary or atypical parkinsonism
•2. Any previous procedure or therapy designed to provide continuous levodopa or stimulation of dopaminergic tone (i.e., Duopa, apomorphine), surgery for PD (i.e., DBS), or anticipation of these during the study
•3. History of exclusively diphasic, OFF state, myoclonic or dystonic dyskinesias without peak-dose choreiform dyskinesia
•4. Clinically debilitating motor complications as determined by the principal investigator or delegate (severe, disabling dyskinesias or severe OFF)
•5. Participant inability to differentiate motor states (OFF/ON/ON with mild/moderate/severe dyskinesias) after training
•6. Clinically significant orthostatic hypotension (consistently symptomatic or requires medication)
•7. Clinically significant hallucinations requiring antipsychotic use
•8. Clinically significant medical, surgical, psychiatric, or laboratory abnormalities that in the judgment of the principal investigator or delegate would preclude adequate participation or completion of the study
•9. Clinically significant ECG abnormalities at Screening
•10. Prolonged Fridericia-corrected QT (QTcF) interval on ECG at Screening (defined as a QTcF interval of \>450 msec for males and 470 for females)
+13 more criteria

Locations (4)

Quest Research Institute

Lake Mary, Florida, United States

Velocity Clinical Research

Durham, North Carolina, United States

CMAX

Adelaide, South Australia, Australia

Monash

Melbourne, Victoria, Australia

Key Dates

Start Date

February 1, 2026

Primary Completion Date

January 31, 2027

Completion Date

January 31, 2027

Last Updated

March 3, 2026

Enrollment

ESTIMATED participants

Conditions

PARKINSON DISEASE (Disorder)Advanced Parkinson's Disease

Interventions

SER-252 (PEOZ-apomorphine)

DRUG

enFuse

DEVICE

Contacts

Randall Moreadith, MD, PhD

CONTACT

(256) 783-7649 rmoreadith@serinatherapeutics.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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