Safety and Pharmacodynamics of SEL-212 (Pegsiticase + SEL-110) in Subjects With Elevated Blood Uric Acid Levels

January 26, 2017 updated by: Selecta Biosciences, Inc.

A Phase I Single Ascending Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 in Subjects With Elevated Blood Uric Acid

This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, 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 and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, 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 and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. Cohorts of subjects in the SEL-110 only arms of the study will be given a single, ascending intravenous dose of SEL-110 and then monitored for safety and rapamycin levels (pharmacokinetics) over 30 days. Cohorts of subjects in the SEL-212 arms of the study will be given a single, ascending intravenous dose of SEL-110 with a fixed dose of SEL-037 and then monitored for safety, rapamycin levels, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days. One additional control group with receive a single intravenous infusion of SEL-037 at a fixed dose and then monitored for safety, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Baptist Health Center for Clinical Research
    • Florida
      • Miami, Florida, United States, 33143
        • Miami Research Associates
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center, Inc.
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • SNBL Clinical Pharmacology Center Inc.
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • DaVita Clinical Research
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Altoona Center for Clincal Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female subjects ages 21 to 70 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 (for arms receiving SEL-037 or SEL-212);
  • 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;
  • Presently taking a drug classified as CYP3A4 inducer or inhibitor;
  • Has participated in a clinical trial within 30 days of the Screening;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEL-110
Single intravenous dose of SEL-110
Drug: SEL-110
Biological: SEL-212
Experimental: SEL-212
Single intravenous dose of SEL-110 plus SEL-037 (pegsiticase)
Biological: SEL-212
Experimental: SEL-037
Single intravenous dose of SEL-037 (pegsiticase)
Biological: SEL-037

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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-110, SEL-212 or SEL-037 as assessed by frequency of drug related adverse events, graded by severity
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
30 days
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
30 days
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
30 days
Pharmacokinetics of SEL-110 (AUC)
Time Frame: 30 days
Measurement of the pharmacokinetics of SEL-110 over 30 days by area under the blood concentration versus time curve (AUC)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Selecta Biosciences, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 5, 2016

First Submitted That Met QC Criteria

January 6, 2016

First Posted (Estimate)

January 7, 2016

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • SEL-212/101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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