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A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Centocor, Inc.
ClinicalTrials.gov Identifier:
NCT01081691
First received: February 18, 2010
Last updated: September 30, 2010
Last verified: September 2010

February 18, 2010
September 30, 2010
February 2010
Not Provided
Safety and tolerability of CNTO 5825 by evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events in healthy volunteers. [ Time Frame: 17 weeks post dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01081691 on ClinicalTrials.gov Archive Site
  • Evaluate the effects of CNTO5825 on the body and the effects of the body on CNTO 5825 (Pharmacokinetics (PK), Pharmacodynamics (PD)) [ Time Frame: 17 weeks post dose ] [ Designated as safety issue: No ]
  • Immune response (Immunogenicity) after dose with CNTO 5825 [ Time Frame: 17 weeks post dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study Evaluating Intravenous and Subcutaneous Administration of a Human Monoclonal Antibody (CNTO 5825) in Healthy Volunteers
A Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CNTO 5825 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects

The purpose of this study is to assess the safety and tolerability of CNTO 5825 following a single intravenous (IV) or subcutaneous (SC) dose administration in healthy volunteers.

This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician or subject knows the name of the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 5825. The study population will consist of 48 healthy volunteers and 16 healthy atopic volunteers. Five dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then return for out-patient visits. Safety assessments will be performed throughout the study and include obtaining and evaluating laboratory tests, vital signs (e.g., blood pressure), and the occurrence and severity of adverse events. Placebo (containing inactive substances only) or one of five dose levels of CNTO 5825 will be given. Healthy volunteers will be given a single IV infusion (directly into a vein) or a single dose of up to 3 injections under the skin. Healthy atopic volunteers will be given one dose as as an IV infusion. There will be a screening period of up to 4 weeks. All participants will be in the study for 17 weeks after dose administration.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
  • Biological: CNTO 5825
    10 mg/kg single dose IV or matching placebo
  • Biological: CNTO 5825
    3 mg/kg single dose IV or matching placebo
  • Biological: CNTO 5825
    For atopic patient:10 mg/kg single IV dose or matching placebo
  • Biological: CNTO 5825
    For atopic patient: 3 mg/kg single dose SC or matching placebo
  • Biological: CNTO 5825
    0.3 mg/kg single dose IV or matching placebo
  • Biological: CNTO 5825
    0.1 mg/kg single dose Intravenously (IV) or matching placebo
  • Biological: CNTO 5825
    1 mg/kg single dose IV or matching placebo
  • Experimental: 001
    CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo
    Intervention: Biological: CNTO 5825
  • Experimental: 002
    CNTO 5825 0.3 mg/kg single dose IV or matching placebo
    Intervention: Biological: CNTO 5825
  • Experimental: 003
    CNTO 5825 1 mg/kg single dose IV or matching placebo
    Intervention: Biological: CNTO 5825
  • Experimental: 004
    CNTO 5825 3 mg/kg single dose IV or matching placebo
    Intervention: Biological: CNTO 5825
  • Experimental: 005
    CNTO 5825 10 mg/kg single dose IV or matching placebo
    Intervention: Biological: CNTO 5825
  • Experimental: 006
    CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo
    Intervention: Biological: CNTO 5825
  • Experimental: 007
    CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo
    Intervention: Biological: CNTO 5825
van Hartingsveldt B, Nnane IP, Bouman-Thio E, Loza MJ, Piantone A, Davis HM, Petty KJ. Safety, tolerability and pharmacokinetics of a human anti-interleukin-13 monoclonal antibody (CNTO 5825) in an ascending single-dose first-in-human study. Br J Clin Pharmacol. 2013 May;75(5):1289-98. doi: 10.1111/j.1365-2125.2012.04477.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
64
September 2010
Not Provided

Inclusion Criteria:

  • Healthy man or woman with no clinically significant abnormalities
  • Body weight in the range of 50 to 100 kg inclusive
  • Body mass index (BMI) of 18.5 to 30 kg/m2 inclusive
  • For healthy atopic patients: history of atopic allergy

Exclusion Criteria:

  • Known or suspected intolerance or hypersensitivity to any biologic medication or to any components of the formulation used in this study
  • Received an experimental antibody or biologic therapy within the previous 6 months
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01081691
CR015574, EudraCT No.: 2009-013343-11
Not Provided
Sr. Director, CPTM, Centocor
Centocor, Inc.
Not Provided
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
Centocor, Inc.
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP