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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
  Purpose

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.


Condition Intervention Phase
Healthy
Biological: CNTO 5825
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Centocor, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: February 2010
Study Completion Date: September 2010
Arms Assigned Interventions
Experimental: 001
CNTO 5825 0.1 mg/kg single dose Intravenously (IV) or matching placebo
Biological: CNTO 5825
0.1 mg/kg single dose Intravenously (IV) or matching placebo
Experimental: 002
CNTO 5825 0.3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
0.3 mg/kg single dose IV or matching placebo
Experimental: 003
CNTO 5825 1 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
1 mg/kg single dose IV or matching placebo
Experimental: 004
CNTO 5825 3 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
3 mg/kg single dose IV or matching placebo
Experimental: 005
CNTO 5825 10 mg/kg single dose IV or matching placebo
Biological: CNTO 5825
10 mg/kg single dose IV or matching placebo
Experimental: 006
CNTO 5825 For atopic patient:10 mg/kg single IV dose or matching placebo
Biological: CNTO 5825
For atopic patient:10 mg/kg single IV dose or matching placebo
Experimental: 007
CNTO 5825 For atopic patient: 3 mg/kg single dose SC or matching placebo
Biological: CNTO 5825
For atopic patient: 3 mg/kg single dose SC or matching placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081691

Sponsors and Collaborators
Centocor, Inc.
Investigators
Study Director: Centocor, Inc. Clinical Trial Centocor, Inc.
  More Information

No publications provided by Centocor, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr. Director, CPTM, Centocor
ClinicalTrials.gov Identifier: NCT01081691     History of Changes
Other Study ID Numbers: CR015574, EudraCT No.: 2009-013343-11
Study First Received: February 18, 2010
Last Updated: September 30, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Centocor, Inc.:
CNTO 5825
Safety
Phase I
Healthy adults
Healthy Atopic adults

ClinicalTrials.gov processed this record on November 19, 2014