An Open-Label, Sequential, Ascending Single-Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of an Intravenous Infusion of SEL-037 in Subjects With Elevated Blood Uric Acid Levels
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Selecta Biosciences, Inc.
- Enrollment
- 22
- Locations
- 4
- Primary Endpoint
- Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity
Study Overview
Brief 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.
Detailed Description
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. Cohorts of Subjects will be given a single, ascending dose intravenous infusion of SEL-037 and then monitored for safety, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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;
Exclusion Criteria
- •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;
Outcomes
Primary Outcomes
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity
Time Frame: 30 days
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
Secondary Outcomes
- Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)(30 days)
- Pharmacokinetics of SEL-037 (AUC)(30 days)
- Pharmacodynamics of SEL-037 (blood uric acid levels)(30 days)