Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01288196 | A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers | PHASE1 | COMPLETED | 32 | — | — | Feb 1, 2011 | Aug 1, 2011 | Jan 28, 2013 | 1 | Belgium |
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | CNTO 6785 1 mg/kg IV A single 30-minute IV infusion of CNTO 6785 1 mg/kg |
| 002 | EXPERIMENTAL | CNTO 6785 3 mg/kg IV A single 30-minute IV infusion of CNTO 6785 3 mg/kg |
| 003 | EXPERIMENTAL | CNTO 6785 10 mg/kg IV A single 30-minute IV infusion of CNTO 6785 10 mg/kg |
| 004 | PLACEBO_COMPARATOR | Placebo IV A single 30-minute IV infusion of placebo |
| 005 | EXPERIMENTAL | CNTO 6785 SC A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections |
| 006 | PLACEBO_COMPARATOR | Placebo SC A single SC dose of placebo administered in up to 3 SC injections |
| Name | Type | Description |
|---|---|---|
| Placebo IV | DRUG | A single 30-minute IV infusion of placebo |
| CNTO 6785 1 mg/kg IV | DRUG | A single 30-minute IV infusion of CNTO 6785 1 mg/kg |
| CNTO 6785 3 mg/kg IV | DRUG | A single 30-minute IV infusion of CNTO 6785 3 mg/kg |
| CNTO 6785 10 mg/kg IV | DRUG | A single 30-minute IV infusion of CNTO 6785 10 mg/kg |
| CNTO 6785 SC | DRUG | A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections |
| Placebo SC | DRUG | A single SC dose of placebo administered in up to 3 SC injections |
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 su...