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

S

Selecta Biosciences

Status and phase

Completed
Phase 1

Conditions

Gout

Treatments

Biological: SEL-037 (pegsiticase)

Study type

Interventional

Funder types

Industry

Identifiers

NCT02464605
SEL-037/101

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

SEL-037 (pegsiticase)
Experimental group
Description:
Pegylated uricase
Treatment:
Biological: SEL-037 (pegsiticase)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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