NCT01093911

Safety Study of CDP7657 in Healthy Volunteers and Patients With Systemic Lupus Erythematosus (SLE)

A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalating Study to Evaluate Safety, Tolerability, Pharmacokinetics, Immunogenicity and to Explore the Pharmacodynamics of CDP7657 Administered in Healthy Subjects and in SLE Patients.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Conditions

• Immune System Diseases
• Autoimmune Diseases
• Lupus Erythematosus, Systemic
• Skin and Connective Tissue Diseases
• Connective Tissue Disease

Interventions

Type	Name	Description
BIOLOGICAL	CDP7657	Ascending single doses of CDP7657
OTHER	Placebo	Placebo: 0.9% sodium chloride aqueous solution

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2010-03-26
• Last updated: 2013-01-04

Locations

8 sites across 3 countries: Belgium, Bulgaria, Germany