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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02224118 | Safety, Pharmacokinetics, and Pharmacodynamics Study of Single Dose of CNTO 3649 in Healthy Adult Men and Multiple Doses of CNTO 3649 in Participants With Type 2 Diabetes Mellitus | PHASE1 | COMPLETED | 64 | — | — | Jul 1, 2009 | Mar 1, 2010 | Sep 9, 2014 | 1 | Japan |
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between administration of study drug and up to 57 for CNTO 3649 10, 30, 100 and 300 microgram per kilogram (mcg/kg) (Part 1); Day 1 to 92 for CNTO 3649 30 and 100 mcg/kg (Part 2) that would be absent before treatment or that may worsen relative to pre-treatment state.
| Arm | Type | Description |
|---|---|---|
| CNTO 3649 10 mcg/kg (single dose) | EXPERIMENTAL | A single dose of 10 microgram per kilogram (mcg/kg) of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men. |
| CNT0 3649 30 mcg/kg (single dose) | EXPERIMENTAL | A single dose of 30 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men. |
| CNTO 3649 100 mcg/kg (single dose) | EXPERIMENTAL | A single dose of 100 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men. |
| CNTO 3649 300 mcg/kg (single dose) | EXPERIMENTAL | A single dose of 300 microgram per kilogram (mcg/kg) of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men. |
| CNT0 3649 30 mcg/kg (multiple dose) | EXPERIMENTAL | Participants with type 2 diabetes mellitus will be administered 30 mcg/kg CNTO 3649 as subcutaneous injection once a week for 4 weeks. |
| CNTO 3649 100 mcg/kg (multiple dose) | EXPERIMENTAL | Participants with type 2 diabetes mellitus will be administered 100 mcg/kg CNTO 3649 as subcutaneous injection once a week for 4 weeks. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo to CNTO 3649 will be administered to both healthy volunteers and participants with type 2 diabetes mellitus. |
| Name | Type | Description |
|---|---|---|
| CNTO 3649 10 mcg/kg | DRUG | A single dose of 10 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men. |
| CNT0 3649 30 mcg/kg | DRUG | A single dose of 30 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men and multiple doses of 30 mcg/kg of CNTO 3649 will be administered to participants with type 2 diabetes mellitus as subcutaneous injections once weekly for 4 weeks. |
| CNTO 3649 100 mcg/kg | DRUG | A single dose of 100 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men and multiple doses of 100 mcg/kg of CNTO 3649 will be administered to participants with type 2 diabetes mellitus as subcutaneous injections once weekly for 4 weeks. |
| CNTO 3649 300 mcg/kg | DRUG | A single dose of 300 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men. |
| Placebo | DRUG | Matching Placebo to CNTO 3649 will be administered to both healthy volunteers and participants with type 2 diabetes mellitus. |
Inclusion Criteria: Part 1 * Weighs greater than or equal to (\>=) 50 kilogram (kg) and less than (\<) 100 kg and has a body mass index (BMI) of \>= 18.5 and \<25.0 at the time of screening tests * Is a non-smoker, or is able to refrain from smoking from 2 days before screening tests until complet...