NCT01838694CompletedPhase 1
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 enrollmentStarted: July 2013Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- 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.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Placebo Comparator
Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.
Intervention: Placebo (Drug)
Ala-Cpn10
Experimental
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 (Biological)
Outcomes
Primary Outcomes
Change From Baseline Serum Interleukin 6 (IL-6) Levels at the End of Active Dosing, Comparing Treatment to Placebo Cohort.
Time Frame: 4 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (6)
Loading locations...
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