A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus

PHASE1CompletedINTERVENTIONAL
Enrollment

133

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

April 30, 2010

Study Completion Date

April 30, 2010

Conditions
Diabetes Mellitus, Type 2
Interventions
DRUG

CNTO 3649 IV (Healthy participants)

Healthy participants will each receive a single dose of CNTO 3649 (1, 3, 10, 30, 100 or 300 microgram per kilogram, subject to change) as a 2-hour IV infusion.

DRUG

CNTO 3649 SC (Healthy participants)

Healthy participants will each receive a single dose of CNTO 3649 (10, 30, 100 or 300 microgram per kilogram, subject to change) as a SC injection.

DRUG

CNTO 3649 SC (Diabetic patients)

Diabetic patients will receive multiple doses of CNTO 3649 (30, 100 or 300 microgram per kilogram, subject to change) as subcutaneous injections once weekly for 4 consecutive weeks.

DRUG

Placebo

Participants within each dosing group who are randomized to placebo will receive a corresponding IV infusion or SC injection of placebo.

Trial Locations (3)

Unknown

Miramar

San Antonio

Tacoma

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Centocor, Inc.

INDUSTRY

NCT00882726 - A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus | Biotech Hunter | Biotech Hunter