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

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

July 31, 2009

Primary Completion Date

March 31, 2010

Study Completion Date

March 31, 2010

Conditions
HealthyDiabetes Mellitus, Type 2
Interventions
DRUG

CNTO 3649 10 mcg/kg

A single dose of 10 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.

DRUG

CNT0 3649 30 mcg/kg

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.

DRUG

CNTO 3649 100 mcg/kg

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.

DRUG

CNTO 3649 300 mcg/kg

A single dose of 300 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.

DRUG

Placebo

Matching Placebo to CNTO 3649 will be administered to both healthy volunteers and participants with type 2 diabetes mellitus.

Trial Locations (1)

Unknown

Fukukoka

Sponsors
All Listed Sponsors
lead

Janssen Pharmaceutical K.K.

INDUSTRY