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

Gout Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464605
• Other study ID #: SEL-037/101
• Status: Completed
• Phase: Phase 1
• First received: May 29, 2015
• Last updated: October 19, 2016
• Start date: May 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2016
• Source: Selecta Biosciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout

Intervention

Biological:
• SEL-037 (pegsiticase)
Intravenous infusion of SEL-037

Locations

Country	Name	City	State
United States	Metroplex Clinical Research Center	Dallas	Texas
United States	Altoona Center for Clincal Research	Duncansville	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Selecta Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Pharmacokinetics of SEL-037 (AUC)	Measurement of the pharmacokinetics of SEL-037 over 30 days by area under the serum concentration versus time curve (AUC)	30 days	No
Secondary	Pharmacodynamics of SEL-037 (blood uric acid levels)	Pharmacodynamics of SEL-037 by measurement of blood uric acid levels over 30 days	30 days	No
Secondary	Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)	Immunogenicity of SEL-037 by measurement of anti-drug antibody levels over 30 days	30 days	No