Healthy
Conditions
Keywords
CNTO 6785, Intravenous, Subcutaneous, Pharmacokinetics, Immunogenicity, Safety, Tolerability
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.
Interventions
DRUGPlacebo IV
A single 30-minute IV infusion of placebo
DRUGCNTO 6785 1 mg/kg IV
A single 30-minute IV infusion of CNTO 6785 1 mg/kg
DRUGCNTO 6785 3 mg/kg IV
A single 30-minute IV infusion of CNTO 6785 3 mg/kg
DRUGCNTO 6785 10 mg/kg IV
A single 30-minute IV infusion of CNTO 6785 10 mg/kg
DRUGCNTO 6785 SC
A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
DRUGPlacebo SC
A single SC dose of placebo administered in up to 3 SC injections
Sponsors
Janssen-Cilag International NV
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and type of Infusion (injection) site reactions | 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 |
| Number and type of adverse events reported | Up to Week 17 |
| Vital signs measurements | Up to Week 17 |
Secondary
| Measure | Time frame |
|---|---|
| Serum antibodies to CNTO 6785 | Up to Week 17 |
| Serum concentration of CNTO 6785 | Up to Week 17 |
Countries
Belgium
Outcome results
None listed