A Study of the Safety, Pharmacokinetics, and Pharmacodynamics of CNTO 3649 in Healthy Adults and Patients With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety, pharmacokinetics, and pharmacodynamics of CNTO 3649 following a single dose in healthy adults and following multiple doses in patients with Type 2 Diabetes Mellitus.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Intravenous and Subcutaneous Single-Dose Study in Healthy Subjects and Ascending Subcutaneous Multiple-Dose Study in Subjects With Type 2 Diabetes Mellitus to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmaco|
- Safety and tolerability of a single IV or SC administration of CNTO 3649 in healthy participants; Safety and tolerability of multiple SC injections of CNTO 3649 in Type 2 Diabetic Patients
- Pharmacokinetics, pharmacodynamics and immunogenicity of CNTO 3649 following single and multiple administrations.
|Study Start Date:||February 2009|
|Study Completion Date:||April 2010|
This is a randomized (study medication assigned by chance), placebo controlled, double-blind (neither physician or patient knows the name of the assigned study medication) study to assess the safety, tolerability, immune response, pharmacokinetics (what the body does to the drug), and pharmacodynamics (what the drug does to the body) of CNTO 3649. The study population will consist of 80 healthy participants and 36 type 2 diabetic patients. Six dose levels of study agent will be assessed. Participants will be required to stay at the research center after study agent administration for the inpatient portion of the study and then return for out-patient visits. Placebo (containing inactive substances only) or one of six dose levels of CNTO 3649 will be given. Healthy subjects will be given a single IV infusion (directly into a vein) or a single dose of up to 2 injections under the skin. Diabetic patients will be given 4 doses as up to 2 injections under the skin (SC) over 4 weeks. There will be a screening period of up to 30 days. Healthy participants will be in the study for 9 weeks. Diabetic patients will be in the study for 12 weeks.