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

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ClinicalTrials.gov Identifier: NCT02464605
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Gout Biological: SEL-037 (pegsiticase) Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
Drug Information available for: Uric Acid

Arm Intervention/treatment
Experimental: SEL-037 (pegsiticase)
Pegylated uricase
Biological: SEL-037 (pegsiticase)
Intravenous infusion of SEL-037




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pharmacokinetics of SEL-037 (AUC) [ Time Frame: 30 days ]
    Measurement of the pharmacokinetics of SEL-037 over 30 days by area under the serum concentration versus time curve (AUC)

  2. Pharmacodynamics of SEL-037 (blood uric acid levels) [ Time Frame: 30 days ]
    Pharmacodynamics of SEL-037 by measurement of blood uric acid levels over 30 days

  3. Immunogenicity of SEL-037 (measurement of anti-drug antibody levels) [ Time Frame: 30 days ]
    Immunogenicity of SEL-037 by measurement of anti-drug antibody levels over 30 days



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464605


Locations
United States, Pennsylvania
Altoona Center for Clincal Research
Duncansville, Pennsylvania, United States, 16635
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Selecta Biosciences, Inc.

Responsible Party: Selecta Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02464605     History of Changes
Other Study ID Numbers: SEL-037/101
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Uric Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs