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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CNTO 6785 1 mg/kg IV; Drug: CNTO 6785 3 mg/kg IV; Drug: Placebo IV; Drug: CNTO 6785 10 mg/kg IV; Drug: CNTO 6785 SC; Drug: Placebo SC

• Registration Number: NCT01288196
• Lead Sponsor: Janssen-Cilag International NV

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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-02-01
• Study First Posted: 2011-02-02
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-25
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
001	CNTO 6785 1 mg/kg IV	CNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg
002	CNTO 6785 3 mg/kg IV	CNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg
004	Placebo IV	Placebo IV A single 30-minute IV infusion of placebo
003	CNTO 6785 10 mg/kg IV	CNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg
005	CNTO 6785 SC	CNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
006	Placebo SC	Placebo SC A single SC dose of placebo administered in up to 3 SC injections

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Serum concentration of CNTO 6785	Up to Week 17
Serum antibodies to CNTO 6785	Up to Week 17