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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01093911

Enrollment

Registered

2010-03-26

Start date

2010-03-31

Completion date

2012-12-31

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Lupus, SLE

Brief summary

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Interventions

BIOLOGICALCDP7657

Ascending single doses of CDP7657

OTHERPlacebo

Placebo: 0.9% sodium chloride aqueous solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame
Assessment of safety of CDP7657 as per Adverse Event (AE) reporting	Day 0 to 119

Secondary

Measure	Time frame
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

Countries

Belgium, Bulgaria, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026