Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT02648269
Eligibility Criteria:
Inclusion Criteria:
* 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;
Exclusion Criteria:
* 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;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
70 Years
Study:
NCT02648269
Study Brief:
Protocol Section:
NCT02648269