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.
Phase 1
Completed
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Drug: PlaceboBiological: Ala-Cpn10
- Registration Number
- NCT01838694
- Lead Sponsor
- Invion, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes. Ala-Cpn10 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.
- Primary Outcome Measures
Name Time Method Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort. 4 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Altoona Arthritis and Osteoporosis Center
🇺🇸Altoona, Pennsylvania, United States
Northwestern University School of Medicine
🇺🇸Chicago, Illinois, United States
Abel Buchheim Pharmaceutical Research
🇺🇸Miami, Florida, United States
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Metroplex Clinical Research Center
🇺🇸Dallas, Texas, United States