Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels
NCT02464605 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2016-10-21
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.
Conditions
Interventions
- BIOLOGICAL
-
SEL-037 (pegsiticase)
Intravenous infusion of SEL-037
Sponsors & Collaborators
-
Selecta Biosciences, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 21 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-05-31
- Primary Completion
- 2015-11-30
- Completion
- 2016-07-31
Countries
- United States
Study Locations
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