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

NCT02224118 ↗

Phase 1 Completed 64 enrolled Janssen Pharmaceutical K.K.
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

EvaluationDrugModalityDoseRoute
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