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
Public ClinicalTrials.gov record NCT02579473. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02579473
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 40 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 2016 (Actual)
- Primary completion
- Dec 31, 2023 (Estimated)
- Completion
- Dec 31, 2023 (Estimated)
- Last update posted
- Apr 11, 2023
2016 – 2023
United States locations
- U.S. sites
- 4
- U.S. states
- 4
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35233 | — |
| MD Clinical | Hallandale | Florida | 33009 | — |
| Georgia Regents University | Augusta | Georgia | 30912 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02579473, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 11, 2023 · Synced Oct 28, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02579473 live on ClinicalTrials.gov.