A Study of Weekly Subcutaneous Injections of SER-214 in Subjects With Parkinson's Disease (PD), to Determine the Safety, Tolerability and Pharmacokinetic (PK) Profile of SER-214

Status unconfirmed · Phase 1

Conditions studied: Parkinson's Disease

In brief

SER-214 is a poly (2-ethyl-2oxazoline)(POZ) polymer conjugate of rotigotine, a potent dopamine agonist that has high affinity for the subclass of dopamine receptors in the brain that mediate dopamine signaling. SER-214 will be administered subcutaneously once a week via a standard 1 mL insulin syringe to determine the safety, tolerability and pharmacokinetic (PK) profile of released rotigotine and POZ-conjugate. Subjects in this study are eligible if they have early, stable or untreated Parkinson's disease and are still experiencing motor fluctuations.

Key facts

Study ID: NCT02579473
Run by: Serina Therapeutics
People needed: 20
Starts: 2016-01-01
Expected to finish: 2023-12-31
Last updated by the study team: 2023-04-11

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Female or male subjects 40-80 years of age inclusive
A diagnosis of idiopathic Parkinson's disease (PD) consistent with UK brain bank criteria
De novo PD patients and those on a stable regimen of anti-Parkinson's drugs for at least 4weeks prior to screening including anticholingerics, amantadine, MAO-B inhibitors, COMT inhibitors or levodopa, but not dopamine agonists
Free of clinically significant motor complications as determined by the investigator
Ability to complete up to four weeks of dosing once per week with two weeks of terminal "wash-out" PK
Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort
Mini Mental State Exam (MMSE) > 26
Women of child-bearing potential (WOCBP) must use a reliable method of contraception (e.g., oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods [such as condom plus diaphragm, condom plus spermicidal foam, condom plus sponge], or intra-uterine devices), and must have a negative serum pregnancy test at Screening and negative urine pregnancy test at baseline
Willing and able to comply with the study requirements including follow-up
Provide written informed consent
Cognitively intact sufficient to understand and provide informed consent
Approved by a central Eligibility Monitoring Committee (EMC) confirmed by EMC signature on the Enrollment Authorization Form (EAF)

You may not qualify if…

Subject has previously participated in this study.
Myocardial infarction within the past six months from screening
Ischemic stroke or transient ischemic event within the past two years from screening
Known sensitivity to dopamine agonists including nausea/vomiting, orthostatic hypotension, excessive sleep or impulse control disorder
Any major organ disease that substantially impairs life expectancy
History of cancer, other than basal cell carcinoma, within the past 10 years or subjects with any laboratory or physical exam or diagnostic procedure finding suggestive of current malignancy
Subjects who are known to be immunosuppressed or are receiving chronic treatment with immunosuppressive drugs
Subject with an atypical or secondary Parkinsonian (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease)
Any clinically significant medical, surgical, or psychiatric condition, laboratory value, or concomitant medication which, in the opinion of the Investigator, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.
Subject has moderate renal impairment (creatine > 2.5)
Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.
Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (CSSRS) at Screening
Subject has known hypersensitivity to rotigotine or to any components or excipients of the study drug
Subject has a history of psychosis or hallucinations within the previous 12 months
Subject has received an investigational drug within 30 days of screening or is currently participating in an investigational drug or investigational device trial
Subject, who, for any reason, is judged by the Investigator to be inappropriate for this study, including a subject who is unable to communicate or cooperate with the Investigator or who has/had a clinically significant illness or abnormal physical examination that may compromise safety of the subject during the trial or affect ability of the subject to adhere to study procedures

Where it is running

University of Alabama Birmingham — Birmingham, Alabama, United States
MD Clinical — Hallandale, Florida, United States
Georgia Regents University — Augusta, Georgia, United States
Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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