A multi-center, open-label, multiple ascending dosage-ranging cohort (MAD) study in early, untreated or stably treated subjects with Parkinson’s disease (PD), to determine the safety, tolerability and pharmacokinetics (PK) of injections of SER-214 administered subcutaneously once a week for two weeks after 0-2 weeks of dose titration

A multi-center, open-label, multiple ascending dosage-ranging cohort (MAD) study in early, untreated or stably treated subjects with Parkinson’s disease (PD), to determine the safety, tolerability and pharmacokinetics (PK) of injections of SER-214 administered subcutaneously once a week for two weeks after 0-2 weeks of dose titration

Recruitment Information:

Seeking volunteers with following diagnosis: PD Study Type: Interventional
Eligible Ages: 40 - 80 Status: Not yet recruiting
Time Since Diagnosis: Less than 15 years Study Focus:

Study Purpose:

Prior to proceeding to multiple dose cohorts 1-3, a 3-5 subject cohort (cohort 0) with a single dose of SER-214 will be completed. Subjects in cohort 0 will receive a single dose of 20 mg SER-214 (equates to ~ 2.4 mg equivalents of rotigotine) in 0.1 mL via subcutaneous delivery in a standard 1 mL tuberculin (TB) syringe. Following the assessments of safety, tolerability and PK in cohort 0 by the Safety Evaluation Committee, the study will transition to an open-label, multiple ascending dose-ranging cohort study (MAD) in early untreated or stably treated Parkinson’s subjects who will receive a subcutaneous injection of SER-214 once a week for two weeks following 0-2 weeks of dose titration depending on the dosing cohort. Three dosing cohorts are planned with ~ 5 subjects in each cohort. Subjects in cohort 1 will receive 50 mg SER-214 (equates to ~ 6 mg equivalents of rotigotine) in 0.25 mL via subcutaneous delivery in a standard 1 mL tuberculin (TB) syringe once a week for two weeks. Subjects in cohort 2 will receive 50 mg SER-214 in 0.25 mL via a subcutaneous delivery in a standard 1 mL TB syringe in week 1 and 100 mg SER-214 (equates to ~ 12 mg equivalents of rotigotine) in 0.5 mL via subcutaneous delivery in a standard 1 mL TB syringe for the subsequent 2 weeks. Subjects in cohort 3 will receive 50 mg SER-214 in 0.25 mL via a subcutaneous delivery in a standard 1 mL TB syringe in week 1, 100 mg SER-214 in 0.5 mL via subcutaneous delivery in a standard 1 mL TB syringe in week 2, and 200 mg SER-214 (which equates to ~ 24 mg equivalents of rotigotine.) in 1 mL via subcutaneous delivery in a standard 1 mL TB syringe in weeks 3 and 4 Subjects will be encouraged to maintain their standard anti-Parkinsonian medications throughout the study, but will be allowed to down-titrate on their current anti-PD medication while up-titrating on study drug.

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More Details

Prior to proceeding to multiple dose cohorts 1-3, a 3-5 subject cohort (cohort 0) with a single dose of SER-214 will be completed. Subjects in cohort 0 will receive a single dose of 20 mg SER-214 (equates to ~ 2.4 mg equivalents of rotigotine) in 0.1 mL via subcutaneous delivery in a standard 1 mL tuberculin (TB) syringe. Following the assessments of safety, tolerability and PK in cohort 0 by the Safety Evaluation Committee, the study will transition to an open-label, multiple ascending dose-ranging cohort study (MAD) in early untreated or stably treated Parkinson’s subjects who will receive a subcutaneous injection of SER-214 once a week for two weeks following 0-2 weeks of dose titration depending on the dosing cohort. Three dosing cohorts are planned with ~ 5 subjects in each cohort. Subjects in cohort 1 will receive 50 mg SER-214 (equates to ~ 6 mg equivalents of rotigotine) in 0.25 mL via subcutaneous delivery in a standard 1 mL tuberculin (TB) syringe once a week for two weeks. Subjects in cohort 2 will receive 50 mg SER-214 in 0.25 mL via a subcutaneous delivery in a standard 1 mL TB syringe in week 1 and 100 mg SER-214 (equates to ~ 12 mg equivalents of rotigotine) in 0.5 mL via subcutaneous delivery in a standard 1 mL TB syringe for the subsequent 2 weeks. Subjects in cohort 3 will receive 50 mg SER-214 in 0.25 mL via a subcutaneous delivery in a standard 1 mL TB syringe in week 1, 100 mg SER-214 in 0.5 mL via subcutaneous delivery in a standard 1 mL TB syringe in week 2, and 200 mg SER-214 (which equates to ~ 24 mg equivalents of rotigotine.) in 1 mL via subcutaneous delivery in a standard 1 mL TB syringe in weeks 3 and 4 Subjects will be encouraged to maintain their standard anti-Parkinsonian medications throughout the study, but will be allowed to down-titrate on their current anti-PD medication while up-titrating on study drug.

Phase: Phase 1 Lead Sponsor: Serina Therapeutics, Inc.
Trial ID: 004237 Sponsor Type: Industry
Country: United States Additional Collaborators or Sponsors:
Estimated Enrollment: 0 Study Start Date: November 2015
Estimated Study Completion Date: December 2016 Source:
Study Website:
This is a FDA Regulated Trial

More Inclusion & Exclusion Criteria

Exclusion Criteria

  • 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.

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