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

Sponsor

UCB Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01093911

Collaborator

(none)

Enrollment

Locations

Arms

33.1

Duration (Months)

5.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Condition or Disease	Intervention/Treatment	Phase
Immune System Diseases Autoimmune Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Connective Tissue Disease	Biological: CDP7657 Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Official Title:

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.

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CDP7657 CDP7657 in dose escalating cohorts	Biological: CDP7657 Ascending single doses of CDP7657
Placebo Comparator: Placebo	Other: Placebo Placebo: 0.9% sodium chloride aqueous solution

Arm

Intervention/Treatment

Experimental: CDP7657

CDP7657 in dose escalating cohorts

Biological: CDP7657

Ascending single doses of CDP7657

Placebo Comparator: Placebo

Other: Placebo

Placebo: 0.9% sodium chloride aqueous solution

Outcome Measures

Primary Outcome Measures

Assessment of safety of CDP7657 as per Adverse Event (AE) reporting [Day 0 to 119]

Secondary Outcome Measures

Maximum plasma concentration (Cmax) [Day 0 to 119]
Time corresponding to Cmax (Tmax) [Day 0 to 119]
Terminal elimination half-life (t 1/2) [Day 0 to 119]
Plasma levels of anti-CDP7657 antibodies [Day 0 to 119]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy Volunteers and subjects with SLE

Exclusion Criteria:

Severe neuropsychiatric or severe renal SLE
History of chronic, recurrent, or recent severe infection
Significant hematologic abnormalities
History of cancer, heart failure, renal disease, liver disease or other serious illness