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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CNTO 6785 1 mg/kg IV; Drug: CNTO 6785 3 mg/kg IV; Drug: CNTO 6785 10 mg/kg IV; Drug: Placebo IV; Drug: CNTO 6785 SC; Drug: Placebo SC

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Merksem, Belgium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: TRIPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 001; CNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg	Drug: CNTO 6785 1 mg/kg IV; A single 30-minute IV infusion of CNTO 6785 1 mg/kg
EXPERIMENTAL: 002; CNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg	Drug: CNTO 6785 3 mg/kg IV; A single 30-minute IV infusion of CNTO 6785 3 mg/kg
EXPERIMENTAL: 003; CNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg	Drug: CNTO 6785 10 mg/kg IV; A single 30-minute IV infusion of CNTO 6785 10 mg/kg
PLACEBO_COMPARATOR: 004; Placebo IV A single 30-minute IV infusion of placebo	Drug: Placebo IV; A single 30-minute IV infusion of placebo
EXPERIMENTAL: 005; CNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections	Drug: CNTO 6785 SC; A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
PLACEBO_COMPARATOR: 006; Placebo SC A single SC dose of placebo administered in up to 3 SC injections	Drug: Placebo SC; A single SC dose of placebo administered in up to 3 SC injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Serum concentration of CNTO 6785	Up to Week 17
Serum antibodies to CNTO 6785	Up to Week 17

Collaborators and Investigators

• Sponsor: Janssen-Cilag International NV

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: February 1, 2011
• First Submitted That Met QC Criteria: February 1, 2011
• First Posted (ESTIMATE): February 2, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2013
• Last Update Submitted That Met QC Criteria: January 25, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Immunogenicity; Subcutaneous; Tolerability; Intravenous; CNTO 6785
• Other Study ID Numbers: CR017752; CNTO6785OPD1001