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A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01288196
First Posted: February 2, 2011
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Janssen-Cilag International NV
  Purpose
The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers.

Condition Intervention Phase
Healthy Drug: Placebo IV Drug: CNTO 6785 1 mg/kg IV Drug: CNTO 6785 3 mg/kg IV Drug: CNTO 6785 10 mg/kg IV Drug: CNTO 6785 SC Drug: Placebo SC Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Immunogenicity of CNTO 6785 Following a Single Intravenous or a Single Subcutaneous Administration in Healthy Subjects

Further study details as provided by Janssen-Cilag International NV:

Primary Outcome Measures:
  • Number and type of adverse events reported [ Time Frame: Up to Week 17 ]
  • Number and type of Infusion (injection) site reactions [ Time Frame: Up to Week 17 ]
  • Vital signs measurements [ Time Frame: Up to Week 17 ]
  • Clinical laboratory test results [ Time Frame: Up to Week 17 ]
  • Findings from cardiology assessments (electrocardiograms [ECGs] and cardiac telemetry) [ Time Frame: Up to Week 17 ]

Secondary Outcome Measures:
  • Serum concentration of CNTO 6785 [ Time Frame: Up to Week 17 ]
  • Serum antibodies to CNTO 6785 [ Time Frame: Up to Week 17 ]

Enrollment: 32
Study Start Date: February 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
CNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg
Drug: CNTO 6785 1 mg/kg IV
A single 30-minute IV infusion of CNTO 6785 1 mg/kg
Experimental: 002
CNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg
Drug: CNTO 6785 3 mg/kg IV
A single 30-minute IV infusion of CNTO 6785 3 mg/kg
Experimental: 003
CNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg
Drug: CNTO 6785 10 mg/kg IV
A single 30-minute IV infusion of CNTO 6785 10 mg/kg
Placebo Comparator: 004
Placebo IV A single 30-minute IV infusion of placebo
Drug: Placebo IV
A single 30-minute IV infusion of placebo
Experimental: 005
CNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
Drug: CNTO 6785 SC
A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
Placebo Comparator: 006
Placebo SC A single SC dose of placebo administered in up to 3 SC injections
Drug: Placebo SC
A single SC dose of placebo administered in up to 3 SC injections

Detailed Description:
This is a randomized (study drug will be assigned by chance), double-blind (neither the volunteer, physician, or study staff will know the identity of the assigned treatment), study to evaluate the safety, tolerability, pharmacokinetics (blood levels of drug) and immunogenicity (development of antibodies to the drug) of a single dose of CNTO 6785 administered to healthy adult volunteers intravenously (in the vein) or by subcutaneous (under the skin) administration to healthy adult volunteers.This will be the first administration of CNTO 6785 to humans; therefore, no clinical experience is available. Healthy volunteers will receive a single dose of 1, 3, or 10 mg/kg of CNTO 6785 or placebo as a 30-minute intravenous (IV) (injection into a blood vessel) infusion or a single dose of 3 mg/kg of CNTO 6785 administered in up to 3 subcutaneous (under the skin) (SC) injections.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult volunteer with no clinically significant abnormalities as determined by the investigator (study physician)
  • Have a body mass index (BMI) between 19-30 kg/m2
  • Be a non-smoker for at least 6 months prior to study participation
  • Women must be postmenopausal or surgically sterile

Exclusion Criteria:

  • Currently have or have a history of any clinically significant medical illness or medical disorders (includes malignancies or serious infections) that the investigator (study physician) considers should exclude the volunteer from the study
  • Major surgery or significant trauma within 12 weeks of screening
  • Any volunteer who plans to undergo elective surgery within 4 weeks prior to study agent administration and through the end of the study
  • Consumes, on average, more than approximately 500 mg/day of caffeine (as contained in 5 cups of tea or coffee or 8 cans of soda or other caffeinated products per day).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288196


Locations
Belgium
Merksem, Belgium
Sponsors and Collaborators
Janssen-Cilag International NV
Investigators
Study Director: Janssen-Cilag International NV Clinical Trial Janssen-Cilag International NV
  More Information

Responsible Party: Janssen-Cilag International NV
ClinicalTrials.gov Identifier: NCT01288196     History of Changes
Other Study ID Numbers: CR017752
CNTO6785OPD1001
First Submitted: February 1, 2011
First Posted: February 2, 2011
Last Update Posted: January 28, 2013
Last Verified: January 2013

Keywords provided by Janssen-Cilag International NV:
CNTO 6785
Intravenous
Subcutaneous
Pharmacokinetics
Immunogenicity
Safety
Tolerability