Double-Blinded, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Biochemical Activity of Intravenous Cpn10 Administration in Subjects With Mild to Moderate SLE.

Invion, Inc.6 sites in 1 country30 target enrollmentJuly 2013

ConditionsLupus Erythematosus, Systemic

InterventionsPlacebo Ala-Cpn10

DrugsPlacebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Lupus Erythematosus, Systemic
Sponsor: Invion, Inc.
Enrollment: 30
Locations: 6
Primary Endpoint: Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the safety, tolerability, and efficacy of 4 weeks intravenous treatment with Cpn10 in subjects with mild to moderate active SLE.

Registry

clinicaltrials.gov

Start Date

July 2013

End Date

August 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Invion, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Placebo

Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.

Intervention: Placebo

Ala-Cpn10

Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.

Intervention: Ala-Cpn10