Safety and Pharmacodynamics of SEL-037 (Pegsiticase) in Subjects With Elevated Blood Uric Acid Levels

Phase 1

Completed

• Conditions: Gout
• Interventions: Biological: SEL-037 (pegsiticase)

• Registration Number: NCT02464605
• Lead Sponsor: Selecta Biosciences, Inc.

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 Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-29
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-08
• Primary Completion: 2015-11
• Study Completion: 2016-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SEL-037 (pegsiticase)	SEL-037 (pegsiticase)	Pegylated uricase

Primary Outcome Measures

Name	Time	Method
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity	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 Outcome Measures

Name	Time	Method
Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)	30 days	Immunogenicity of SEL-037 by measurement of anti-drug antibody levels over 30 days
Pharmacokinetics of SEL-037 (AUC)	30 days	Measurement of the pharmacokinetics of SEL-037 over 30 days by area under the serum concentration versus time curve (AUC)
Pharmacodynamics of SEL-037 (blood uric acid levels)	30 days	Pharmacodynamics of SEL-037 by measurement of blood uric acid levels over 30 days

Trial Locations

Locations (2)

Altoona Center for Clincal Research; 🇺🇸 Duncansville, Pennsylvania, United States

Metroplex Clinical Research Center; 🇺🇸 Dallas, Texas, United States