Trial · NCT02579473
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
NCT02579473, Phase 1, Unknown, Serina Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT02579473. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02579473
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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
- NCT number
- NCT02579473
- Status
- Unknown
- Phases
- Phase 1
- Enrollment
- 20 participants, estimated
- Lead sponsor
- Serina Therapeutics
- Conditions
- Parkinson's Disease
- Interventions
- SER-214
- First posted
- 2015-10-19
- Last updated
- 2023-04-11
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety - Adverse Events and Serious Adverse Events | From initial sc dose of SER-214 up to six weeks of follow-up | Change from Screening in frequency of adverse events (AEs) and serious adverse events (SAEs) at the Final Safety Visit |
| Primary | Percentage of patients in each cohort who discontinued therapy due to any adverse events {Tolerability} | From initial sc dose of SER-214 up to six weeks of follow-up | Percentage of patients in each cohort who discontinued therapy due to any adverse events will be used as an assessment of tolerability |
| Primary | Safety - Vital Signs | From initial sc dose of SER-214 up to six weeks of follow-up | Change from Screening in assessment of vital signs (pulse, blood pressure) at each study visit and Final Safety Visit |
| Primary | Safety - Abnormal Laboratory Results | From initial sc dose of SER-214 up to six weeks of follow-up | Change from Screening in number of participants with laboratory test values of potential clinical importance |
| Primary | Safety - Treatment-Emergent Adverse Events | From initial sc dose of SER-214 up to six weeks of follow-up | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to \[study drug\] will be assessed by the investigator (Yes/No). |
| Primary | Safety - ECG Changes | From initial sc dose of SER-214 up to six weeks of follow-up | Change from Screening in assessment of electrocardiogram (ECG) parameters at each injection visit |
| Secondary | Fluctuation index | On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours | On injection days plasma samples will be taken at time 0 (baseline), 1, 2, 4 and 8 hours post injection. PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the Fluctuation Index |
| Secondary | Maximum plasma concentration [C(max)] | On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours | PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the C(max) |
| Secondary | Time to maximum concentration [T(max)] | On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours | PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the T(max) |
| Secondary | Dose-adjusted area under the curve (AUC) | On injection days plasma samples will be taken at time 0, 1, 2, 4 and 8 hours | PK samples will be used to determine (a) released plasma rotigotine and (b) total SER-214. PK data will be used to determine the dose-adjusted AUC |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24014074 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02579473
GET https://conductscience.org/api/trials/v1/NCT02579473/registered