NCT01288196

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Janssen-Cilag International NV · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Placebo IV	A single 30-minute IV infusion of placebo
DRUG	CNTO 6785 1 mg/kg IV	A single 30-minute IV infusion of CNTO 6785 1 mg/kg
DRUG	CNTO 6785 3 mg/kg IV	A single 30-minute IV infusion of CNTO 6785 3 mg/kg
DRUG	CNTO 6785 10 mg/kg IV	A single 30-minute IV infusion of CNTO 6785 10 mg/kg
DRUG	CNTO 6785 SC	A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
DRUG	Placebo SC	A single SC dose of placebo administered in up to 3 SC injections

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2011-02-02
• Last updated: 2013-01-28

Locations

1 site across 1 country: Belgium