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OpenTrials
Completed

NCT Number: NCT01093911

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

To evaluate safety, tolerability, pharmacokinetics and immunogenicity of CDP7657

Completed

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

6, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CDP7657

Biological

Ascending single doses of CDP7657

Placebo

Other

Placebo: 0.9% sodium chloride aqueous solution

Primary outcomes

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

    Time frame: Day 0 to 119

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: Day 0 to 119

  2. Time corresponding to Cmax (Tmax)

    Time frame: Day 0 to 119

  3. Terminal elimination half-life (t 1/2)

    Time frame: Day 0 to 119

  4. Plasma levels of anti-CDP7657 antibodies

    Time frame: Day 0 to 119

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2010
Registry last updated
Jan 4, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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