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NCT02464605 · ClinicalTrials.gov registry record · Phase 1
Safety and Pharmacodynamics of SEL-037 (Pegsiticase) 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
- 22
- Enrollment target
- 2
- Study locations
NCT02464605: Completed Phase 1 study of Gout, sponsored by Selecta Biosciences.
NCT02464605 is a Phase 1 study of Gout that has completed, run by Selecta Biosciences. The registered enrollment target is 22 participants, below the 8,888-participant average among 34 other Gout trials with a reported enrollment target (100% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02464605, a Phase 1 study of Gout, has completed, sponsored by Selecta Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 2
- Study locations
Study Summary
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, 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.
Primary Outcome
To assess the safety and tolerability of a single infusion of SEL-037 as assessed by frequency of drug related adverse events, graded by severity
Conditions Studied
Interventions
- BIOLOGICAL SEL-037 (pegsiticase)
Study Locations (2)
Pennsylvania
- Altoona Center for Clincal Research - Duncansville
Texas
- Metroplex Clinical Research Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-07 |
| Phase | Phase 1 |
What the finished NCT02464605 record still lists
NCT02464605 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 8,888-participant average among 34 other Gout trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Gout appearing as the primary indexed condition, and to 1 intervention - of which SEL-037 (pegsiticase) is the first listed.
NCT02464605 reports a single indexed study location in Pennsylvania, Texas.
Frequently Asked Questions
What is clinical trial NCT02464605 about?
NCT02464605 is a clinical study titled "Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels". This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin t...
What is the current status of trial NCT02464605?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2015-05. Estimated completion is 2016-07.
What conditions does trial NCT02464605 study?
This clinical trial studies the following conditions: Gout.
What interventions are being tested in trial NCT02464605?
The interventions under investigation include: SEL-037 (pegsiticase) (BIOLOGICAL).
Who is sponsoring clinical trial NCT02464605?
This trial is sponsored by Selecta Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02464605 being conducted?
This trial has 2 study locations across Pennsylvania, Texas. 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 NCT02464605's enrollment target sits among peer trials
22 29th of 34 higher than 6 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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