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

Sponsor:	UCB, Inc.
Information provided by (Responsible Party):	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT01093911

Purpose

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

MedlinePlus related topics: Autoimmune Diseases Connective Tissue Disorders Lupus

U.S. FDA Resources

Further study details as provided by UCB, Inc.:

Primary Outcome Measures:

Assessment of safety of CDP7657 as per Adverse Event (AE) reporting [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Maximum plasma concentration (Cmax) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
Time corresponding to Cmax (Tmax) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
Terminal elimination half-life (t 1/2) [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]
Plasma levels of anti-CDP7657 antibodies [ Time Frame: Day 0 to 119 ] [ Designated as safety issue: No ]

Estimated Enrollment:	44
Study Start Date:	March 2010
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Criteria

Inclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093911

Contacts

Contact: UCB Clinical Trial Call Center

+1 877 822 9493

Locations

Sponsors and Collaborators

UCB, Inc.

Investigators

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

More Information

No publications provided

Responsible Party:	UCB, Inc.
ClinicalTrials.gov Identifier:	NCT01093911 History of Changes
Other Study ID Numbers:	SL0013, 2009-013617-10
Study First Received:	March 12, 2010
Last Updated:	May 10, 2012
Health Authority:	Germany: Paul-Ehrlich-Institut Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by UCB, Inc.:

Lupus
SLE

Additional relevant MeSH terms:

Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Lupus Erythematosus, Systemic

ClinicalTrials.gov processed this record on May 24, 2012