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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01288196
• Other study ID #: CR017752
• Secondary ID: CNTO6785OPD1001
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2011
• Last updated: January 25, 2013
• Start date: February 2011
• Est. completion date: August 2011

Study information

• Verified date: January 2013
• Source: Janssen-Cilag International NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ministry of Social Affairs, Public Health and the Environment
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Placebo IV
A single 30-minute IV infusion of placebo
• CNTO 6785 1 mg/kg IV
A single 30-minute IV infusion of CNTO 6785 1 mg/kg
• CNTO 6785 3 mg/kg IV
A single 30-minute IV infusion of CNTO 6785 3 mg/kg
• CNTO 6785 10 mg/kg IV
A single 30-minute IV infusion of CNTO 6785 10 mg/kg
• CNTO 6785 SC
A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
• Placebo SC
A single SC dose of placebo administered in up to 3 SC injections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag International NV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and type of adverse events reported		Up to Week 17	No
Primary	Number and type of Infusion (injection) site reactions		Up to Week 17	No
Primary	Vital signs measurements		Up to Week 17	No
Primary	Clinical laboratory test results		Up to Week 17	No
Primary	Findings from cardiology assessments (electrocardiograms [ECGs] and cardiac telemetry)		Up to Week 17	No
Secondary	Serum concentration of CNTO 6785		Up to Week 17	No
Secondary	Serum antibodies to CNTO 6785		Up to Week 17	No