Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels
Completed · Phase 1
Conditions studied: Gout
In brief
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.
Key facts
- Study ID
- NCT02648269
- Run by
- Selecta Biosciences, Inc.
- People needed
- 63
- Starts
- 2015-12-01
- Expected to finish
- 2016-12-01
- Last updated by the study team
- 2017-01-30
Who can join
Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female subjects ages 21 to 70 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 (for arms receiving SEL-037 or SEL-212);
- 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;
- Presently taking a drug classified as CYP3A4 inducer or inhibitor;
- Has participated in a clinical trial within 30 days of the Screening;
Where it is running
- Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
- Miami Research Associates — Miami, Florida, United States
- Orlando Clinical Research Center, Inc. — Orlando, Florida, United States
- SNBL Clinical Pharmacology Center Inc. — Baltimore, Maryland, United States
- Davita Clinical Research — Minneapolis, Minnesota, United States
- Altoona Center for Clincal Research — Duncansville, Pennsylvania, United States
Full record on ClinicalTrials.gov
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