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

NCT ID: NCT02464605

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-07-31

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.

Conditions

Gout

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SEL-037 (pegsiticase)

Pegylated uricase

Group Type: EXPERIMENTAL

SEL-037 (pegsiticase)

Intervention Type: BIOLOGICAL

Intravenous infusion of SEL-037

Interventions

SEL-037 (pegsiticase)

Intravenous infusion of SEL-037

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Selecta Biosciences, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Altoona Center for Clincal Research

Duncansville, Pennsylvania, United States

Metroplex Clinical Research Center

Dallas, Texas, United States

Countries

United States

References

Sands E, Kivitz A, DeHaan W, Leung SS, Johnston L, Kishimoto TK. Tolerogenic nanoparticles mitigate the formation of anti-drug antibodies against pegylated uricase in patients with hyperuricemia. Nat Commun. 2022 Jan 12;13(1):272. doi: 10.1038/s41467-021-27945-7.

Reference Type: DERIVED

PMID: 35022448 (View on PubMed)

Other Identifiers

SEL-037/101

Identifier Type: -

Identifier Source: org_study_id