NCT02648269

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 5, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 5, 2016

Last Update Submit

January 26, 2017

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-110, SEL-212 or SEL-037 as assessed by frequency of drug related adverse events, graded by severity

    30 days

Secondary Outcomes (4)

  • Pharmacokinetics of SEL-110 (AUC)

    30 days

  • 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 (3)

SEL-110

EXPERIMENTAL

Single intravenous dose of SEL-110

Drug: SEL-110Biological: SEL-212

SEL-212

EXPERIMENTAL

Single intravenous dose of SEL-110 plus SEL-037 (pegsiticase)

Biological: SEL-212

SEL-037

EXPERIMENTAL

Single intravenous dose of SEL-037 (pegsiticase)

Biological: SEL-037

Interventions

SEL-110DRUG
SEL-110
SEL-212BIOLOGICAL
SEL-110SEL-212
SEL-037BIOLOGICAL
SEL-037

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Baptist Health Center for Clinical Research

Little Rock, Arkansas, 72205, United States

Location

Miami Research Associates

Miami, Florida, 33143, United States

Location

Orlando Clinical Research Center, Inc.

Orlando, Florida, 32809, United States

Location

SNBL Clinical Pharmacology Center Inc.

Baltimore, Maryland, 21201, United States

Location

Davita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

Altoona Center for Clincal Research

Duncansville, Pennsylvania, 16635, 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: 35022448DERIVED

MeSH Terms

Conditions

Gout

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2016

First Posted

January 7, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 30, 2017

Record last verified: 2017-01

Locations

US(6)