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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Placebo IV
* Drug: CNTO 6785 1 mg/kg IV
* Drug: CNTO 6785 3 mg/kg IV
* Drug: CNTO 6785 10 mg/kg IV
* Drug: CNTO 6785 SC
* Drug: Placebo SC


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CNTO 6785, Intravenous, Subcutaneous, Pharmacokinetics, Immunogenicity, Safety, Tolerability