Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels
Completed · Phase 1
Conditions studied: Gout
In brief
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.
Key facts
- Study ID
- NCT02464605
- Run by
- Selecta Biosciences, Inc.
- People needed
- 22
- Starts
- 2015-05-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2016-10-21
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subjects ages 21 to 75 inclusive. Female subjects must be of non-childbearing potential;
- Has at the Screening Visit a serum uric acid ≥ 6 mg/dL, with or without a history of gout;
- The use of allopurinol, febuxostat (Uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the Screening Visit
- Has adequate venous access and able to receive IV therapy;
- Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study;
You may not qualify if…
- Prior exposure to any experimental or marketed uricase;
- History of any allergy to pegylated products,
- Glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency;
- History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
- Has participated in a clinical trial within 30 days of the Screening;
Where it is running
- Altoona Center for Clincal Research — Duncansville, Pennsylvania, United States
- Metroplex Clinical Research Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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