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

NCT02464605 | Completed Phase 1

• 1 other identifier: SEL-037/101
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity

  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

  30 days

Secondary Outcomes (3)

• Pharmacokinetics of SEL-037 (AUC)

  30 days

• Pharmacodynamics of SEL-037 (blood uric acid levels)

  30 days

• Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)

  30 days

Study Arms (1)

SEL-037 (pegsiticase)

EXPERIMENTAL

Pegylated uricase

Biological: SEL-037 (pegsiticase)

Interventions

SEL-037 (pegsiticase) BIOLOGICAL

Intravenous infusion of SEL-037

SEL-037 (pegsiticase)

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Selecta Biosciences, Inc.: lead

Study Sites (2)

Altoona Center for Clincal Research

Duncansville, Pennsylvania, 16635, United States

Location

Metroplex Clinical Research Center

Dallas, Texas, 75231, United States

Location

Related Publications (1)

• 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.

  PMID: 35022448 DERIVED

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 8, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: July 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

US (2)