A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers - Full Text View

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 Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
Number and type of Infusion (injection) site reactions [ Time Frame: Up to Week 17 ] [ Designated as safety issue: No ]
Vital signs measurements [ Time Frame: Up to Week 17 ] [ Designated as safety issue: No ]
Clinical laboratory test results [ Time Frame: Up to Week 17 ] [ Designated as safety issue: No ]
Findings from cardiology assessments (electrocardiograms [ECGs] and cardiac telemetry) [ Time Frame: Up to Week 17 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum concentration of CNTO 6785 [ Time Frame: Up to Week 17 ] [ Designated as safety issue: No ]
Serum antibodies to CNTO 6785 [ Time Frame: Up to Week 17 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
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

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

No publications provided

Responsible Party:	Janssen-Cilag International NV
ClinicalTrials.gov Identifier:	NCT01288196 History of Changes
Other Study ID Numbers:	CR017752, CNTO6785OPD1001
Study First Received:	February 1, 2011
Last Updated:	January 25, 2013
Health Authority:	Belgium: Ministry of Social Affairs, Public Health and the Environment

Keywords provided by Janssen-Cilag International NV:

CNTO 6785
Intravenous
Subcutaneous
Pharmacokinetics

Immunogenicity
Safety
Tolerability

ClinicalTrials.gov processed this record on May 16, 2013