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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CNTO 6785 10 mg/kg IV; Drug: Placebo IV; Drug: CNTO 6785 1 mg/kg IV; Drug: CNTO 6785 3 mg/kg IV; Drug: Placebo SC; Drug: CNTO 6785 SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT01288196

CNTO6785OPD1001

CR017752

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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32 participants in 6 patient groups, including a placebo group

001

Experimental group

Description:

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

Treatment:

Drug: CNTO 6785 1 mg/kg IV

002

Experimental group

Description:

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

Treatment:

Drug: CNTO 6785 3 mg/kg IV

003

Experimental group

Description:

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

Treatment:

Drug: CNTO 6785 10 mg/kg IV

004

Placebo Comparator group

Description:

Placebo IV A single 30-minute IV infusion of placebo

Treatment:

Drug: Placebo IV

005

Experimental group

Description:

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

Treatment:

Drug: CNTO 6785 SC

006

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo SC