An Ascending Single Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Sbi-087 Administered To Subjects With Systemic Lupus Erythematosus.

Pfizer6 sites in 1 country30 target enrollmentMarch 2009

ConditionsLupus Erythematosus, Systemic

InterventionsSBI-087

DrugsSBI-087

Overview

Phase: Phase 1
Intervention: SBI-087
Conditions: Lupus Erythematosus, Systemic
Sponsor: Pfizer
Enrollment: 30
Locations: 6
Primary Endpoint: 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)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

September 2012

Last Updated

7 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology \[ACR\] Revised Criteria) greater than 6 months before study day
•History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent.

Exclusion Criteria

•Treatment with more than 20 mg of prednisone per day.
•Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE.
•History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state.

Arms & Interventions

SBI-087

Intervention: SBI-087

Outcomes

Primary Outcomes

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