drugset / Trial / 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
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to investigate the safety (adverse events, weight, blood pressure, pulse rate, body temperature, abdominal ultrasonography, standard 12-lead electrocardiography, and laboratory tests) of CNTO 3649 when administered once by subcutaneous injection in healthy adult Japanese men or once a week for 4 weeks in Japanese participants with type 2 diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects).
Timeline
- Start
- 2009-07
- Primary completion
- 2010-03
- Completion
- 2010-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CNTO 3649 | Unknown | 10 ug/kg | Subcutaneous |
| Subject | CNTO 3649 | Unknown | 30 ug/kg | Subcutaneous |
| Subject | CNTO 3649 | Unknown | 100 ug/kg | Subcutaneous |
| Subject | CNTO 3649 | Unknown | 300 ug/kg | Subcutaneous |