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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: Completed Phase 1 study of Gout, sponsored by Selecta Biosciences.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To assess the safety and tolerability of a single infusion of SEL-110, SEL-212 or SEL-037 as assessed by frequency of drug related adverse events, graded by severity
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 |
What the finished NCT02648269 record still lists
NCT02648269 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 8,886-participant average among 34 other Gout trials with a reported enrollment target (99% lower).
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 lists 6 locations in 5 states (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.
Learn More About Clinical Trials
Similar trials for Gout
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02648269's enrollment target sits among peer trials
63 20th of 34 higher than 15 of 34 other Gout trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gout trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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