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

NCT ID: NCT01288196

Last Updated: 2013-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-08-31

Brief Summary

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

001

CNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg

Group Type: EXPERIMENTAL

CNTO 6785 1 mg/kg IV

Intervention Type: DRUG

A single 30-minute IV infusion of CNTO 6785 1 mg/kg

002

CNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg

Group Type: EXPERIMENTAL

CNTO 6785 3 mg/kg IV

Intervention Type: DRUG

A single 30-minute IV infusion of CNTO 6785 3 mg/kg

003

CNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg

Group Type: EXPERIMENTAL

CNTO 6785 10 mg/kg IV

Intervention Type: DRUG

A single 30-minute IV infusion of CNTO 6785 10 mg/kg

004

Placebo IV A single 30-minute IV infusion of placebo

Group Type: PLACEBO_COMPARATOR

Placebo IV

Intervention Type: DRUG

A single 30-minute IV infusion of placebo

005

CNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections

Group Type: EXPERIMENTAL

CNTO 6785 SC

Intervention Type: DRUG

A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections

006

Placebo SC A single SC dose of placebo administered in up to 3 SC injections

Group Type: PLACEBO_COMPARATOR

Placebo SC

Intervention Type: DRUG

A single SC dose of placebo administered in up to 3 SC injections

Interventions

Placebo IV

A single 30-minute IV infusion of placebo

Intervention Type: DRUG

CNTO 6785 1 mg/kg IV

A single 30-minute IV infusion of CNTO 6785 1 mg/kg

Intervention Type: DRUG

CNTO 6785 3 mg/kg IV

A single 30-minute IV infusion of CNTO 6785 3 mg/kg

Intervention Type: DRUG

CNTO 6785 10 mg/kg IV

A single 30-minute IV infusion of CNTO 6785 10 mg/kg

Intervention Type: DRUG

CNTO 6785 SC

A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections

Intervention Type: DRUG

Placebo SC

A single SC dose of placebo administered in up to 3 SC injections

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Merksem, , Belgium

Countries

Belgium

Other Identifiers

CNTO6785OPD1001

Identifier Type: -

Identifier Source: secondary_id

CR017752

Identifier Type: -

Identifier Source: org_study_id