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

Phase 1CompletedNCT01093911

UCB Pharma44 enrolled

Overview

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

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

Interventions

CDP7657BIOLOGICAL

Ascending single doses of CDP7657

PlaceboOTHER

Placebo: 0.9% sodium chloride aqueous solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

Leuven, Belgium

Sofia, Bulgaria

Berlin, Germany

Erlangen, Germany

Frankfurt, Germany

Outcomes

Primary Outcomes

Assessment of safety of CDP7657 as per Adverse Event (AE) reporting

Time frame: Day 0 to 119

Secondary Outcomes

Maximum plasma concentration (Cmax)

Time frame: Day 0 to 119

Time corresponding to Cmax (Tmax)

Time frame: Day 0 to 119

Terminal elimination half-life (t 1/2)

Time frame: Day 0 to 119

Plasma levels of anti-CDP7657 antibodies

Time frame: Day 0 to 119

Data from ClinicalTrials.gov

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