Approval Probability
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ML Risk
CNTO 3649/kg · 1 trial · 2 indications
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...
CNTO 3649/kg is an investigational small molecule developed by Johnson & Johnson for type 2 diabetes mellitus. It was studied in a Phase 1 clinical trial that evaluated single doses in healthy adult men and multiple doses in participants with type 2 diabetes. It is not an approved medicine.
CNTO 3649/kg was being studied for the treatment of type 2 diabetes mellitus. The Phase 1 program assessed its safety, pharmacokinetics, and pharmacodynamics, including single dosing in healthy adult men and multiple dosing in participants with type 2 diabetes. No approved use has been established for this investigational agent.
CNTO 3649/kg is developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the Phase 1 study of the compound in type 2 diabetes mellitus and healthy adult male volunteers.
CNTO 3649/kg is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The study enrolled 64 participants and was conducted in Japan. The drug remains investigational and has not been approved for any indication.
CNTO 3649/kg was evaluated in the Phase 1 trial NCT02224118, titled a study of safety, pharmacokinetics, and pharmacodynamics of single doses in healthy adult men and multiple doses in participants with type 2 diabetes mellitus. The trial was completed, enrolled 64 participants, and was placebo controlled.