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NCT02648269 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels
A Phase 1 study of Gout, sponsored by Selecta Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 6
- Study locations
NCT02648269 is a Phase 1 study of Gout that has completed, run by Selecta Biosciences. The registered enrollment target is 63 participants, below the 8,886-participant average among 34 other Gout trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 5 states.
The verdict
NCT02648269, a Phase 1 study of Gout, has completed, sponsored by Selecta Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 6
- Study locations
Study Summary
This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming.
Conditions Studied
Interventions
- DRUG SEL-110
- BIOLOGICAL SEL-212
- BIOLOGICAL SEL-037
Study Locations (6)
Florida
- Miami Research Associates - Miami
- Orlando Clinical Research Center, Inc. - Orlando
Arkansas
- Baptist Health Center for Clinical Research - Little Rock
Maryland
- SNBL Clinical Pharmacology Center Inc. - Baltimore
Minnesota
- Davita Clinical Research - Minneapolis
Pennsylvania
- Altoona Center for Clincal Research - Duncansville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02648269
The ClinicalTrials.gov registry entry for NCT02648269 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 8,886-participant average among 34 other Gout trials with a reported enrollment target (99% lower). The listed sponsor is Selecta Biosciences, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gout appearing as the primary indexed condition, and to 3 interventions - of which SEL-110 is the first listed.
NCT02648269 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Florida, Arkansas, Maryland.
Frequently Asked Questions
What is clinical trial NCT02648269 about?
NCT02648269 is a clinical study titled "Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels". This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics ...
What is the current status of trial NCT02648269?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2015-12. Estimated completion is 2016-12.
What conditions does trial NCT02648269 study?
This clinical trial studies the following conditions: Gout.
What interventions are being tested in trial NCT02648269?
The interventions under investigation include: SEL-110 (DRUG), SEL-212 (BIOLOGICAL), SEL-037 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02648269?
This trial is sponsored by Selecta Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02648269 being conducted?
This trial has 6 study locations across Arkansas, Florida, Maryland, Minnesota, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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