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: Completed
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.

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
Primary 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

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