Clinical Trial: Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of SBI-087 Administered To Subjects With Systemic Lupus Erythematosus

Brief Summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Safety (physical examinations, laboratory tests, adverse events) and tolerability (dose-limiting toxicities) of ascending single doses of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) [ Time Frame: 12 months ]

Original Primary Outcome: Safety (physical examinations, laboratory tests, adverse events) and tolerability (dose-limiting toxicities) of ascending single doses of SBI-087 in subjects with SLE [ Time Frame: 12 months ]

Current Secondary Outcome: Initial pharmacokinetic and pharmacodynamic profiles of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE) [ Time Frame: 12 months ]

Original Secondary Outcome: Initial PK and PD profiles of SBI-087 in subjects with SLE [ Time Frame: 12 months ]

Information By: Pfizer

Dates:
Date Received: July 8, 2008
Date Started: February 2009
Date Completion:
Last Updated: December 20, 2012
Last Verified: December 2012