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: Active, not recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Serina Therapeutics
• Treatments: N 0437; Rotigotine

Criteria

Inclusion Criteria:

1. Female or male subjects 40-80 years of age inclusive

2. A diagnosis of idiopathic Parkinson's disease (PD) consistent with UK brain bank criteria

3. 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

4. Free of clinically significant motor complications as determined by the investigator

5. Ability to complete up to four weeks of dosing once per week with two weeks of terminal "wash-out" PK

6. Ability to return to the clinic for blood sampling, clinical and laboratory assessment on scheduled days, based upon cohort

7. Mini Mental State Exam (MMSE) > 26

8. 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

9. Willing and able to comply with the study requirements including follow-up

10. Provide written informed consent

11. Cognitively intact sufficient to understand and provide informed consent

12. Approved by a central Eligibility Monitoring Committee (EMC) confirmed by EMC signature on the Enrollment Authorization Form (EAF)

Exclusion Criteria:

1. Subject has previously participated in this study.

2. Myocardial infarction within the past six months from screening

3. Ischemic stroke or transient ischemic event within the past two years from screening

4. Known sensitivity to dopamine agonists including nausea/vomiting, orthostatic hypotension, excessive sleep or impulse control disorder

5. Any major organ disease that substantially impairs life expectancy

6. 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

7. Subjects who are known to be immunosuppressed or are receiving chronic treatment with immunosuppressive drugs

8. Subject with an atypical or secondary Parkinsonian (e.g., due to drugs, metabolic neurogenetic disorders, encephalitis, cerebrovascular disease or degenerative disease)

9. 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.

10. Subject has moderate renal impairment (creatine > 2.5)

11. Subject has moderate (Child-Pugh categorization B, score 7-9) or severe (Child-Pugh categorization C, score 10-15) hepatic impairment.

12. 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

13. Subject has known hypersensitivity to rotigotine or to any components or excipients of the study drug

14. Subject has a history of psychosis or hallucinations within the previous 12 months

15. Subject has received an investigational drug within 30 days of screening or is currently participating in an investigational drug or investigational device trial

16. 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