Clinical trial NCT01288196: A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: CNTO 6785
Intravenous
Subcutaneous
Pharmacokinetics
Immunogenicity
Safety
Tolerability
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2011-02-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number and type of adverse events reported
timeFrame: Up to Week 17
measure: Number and type of Infusion (injection) site reactions
timeFrame: Up to Week 17
measure: Vital signs measurements
timeFrame: Up to Week 17
measure: Clinical laboratory test results
timeFrame: Up to Week 17
measure: Findings from cardiology assessments (electrocardiograms [ECGs] and cardiac telemetry)
timeFrame: Up to Week 17
Secondary outcomes:
measure: Serum concentration of CNTO 6785
timeFrame: Up to Week 17
measure: Serum antibodies to CNTO 6785
timeFrame: Up to Week 17
Other outcomes:
Locations:
city: Merksem
country: Belgium
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References: