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

Janssen-Cilag International NV0 sites32 target enrollmentFebruary 2011

ConditionsHealthy

InterventionsCNTO 6785 1 mg/kg IV CNTO 6785 3 mg/kg IV CNTO 6785 10 mg/kg IV Placebo IV CNTO 6785 SC Placebo SC

DrugsPlacebo IV CNTO 6785 1 mg/kg IV CNTO 6785 3 mg/kg IV CNTO 6785 10 mg/kg IV CNTO 6785 SC Placebo SC

Overview

Phase: Phase 1
Intervention: CNTO 6785 1 mg/kg IV
Conditions: Healthy
Sponsor: Janssen-Cilag International NV
Enrollment: 32
Primary Endpoint: Number and type of Infusion (injection) site reactions
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

August 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Janssen-Cilag International NV

Responsible Party

Sponsor

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).