This will be a randomized (the treatment is assigned by chance), double-blind (neither the participants nor study staff know the identity of the assigned treatment), placebo-controlled study (one of the study medications is inactive) to investigate the pharmacokinetics (ie, how the body absorbs and removes the study drug) and safety of subcutaneous (administered under the skin) (SC) CNTO 3157 (a drug currently being investigated for the treatment of asthma) in both Japanese and Caucasian men. Additionally, an open-label cohort (where participants and study staff know the identity of the assigned treatment) in Caucasian men will investigate the pharmacokinetics and safety of a single intravenous (into a vein) (IV) infusion. The study will consist of 3 phases: a screening phase, a treatment phase (comprising 2 days and 1 night at the study center) and a follow-up period (comprising approximately 11 visits to the study center). During the double-blind SC treatment period, participants will be randomly assigned to 1 of 3 treatment groups: group 1 will receive a single SC injection of 100 mg CNTO 3157 or placebo; group 2 will receive 2 SC injections of CNTO 3157 (making a total dose of 300mg) or placebo; group 3 will receive 4 SC injections of CNTO 3157 (making a total dose of 600 mg) or placebo. Group 4 (open-label cohort) will receive a single IV infusion of 300 mg CNTO 3157. Participants will be enrolled in each SC dose group sequentially from the lower to higher dose level. The study sponsor and the study doctor will review the test results (in terms of safety and tolerability) for each group before dosing participants in the next treatment group; this review will be carried out in a blinded manner. An equal number of Japanese and Caucasian participants will be assigned to the SC treatment groups forming 2 subgroups within each group (groups 1A, 1B, 2A, 2B, 3A and 3B). Within each SC treatment group, 10 participants will be randomly assigned in a 4 to 1 ratio to receive CNTO 3157 or placebo. Only Caucasian participants will be enrolled in the IV treatment group (group 4). For each treatment group, blood and urine samples will be taken at various time points during the study. Each participant will take part in the study for approximately 85 days. Participant safety will be monitored throughout the study.
The purpose of this study is to find out if different doses of CNTO 3157 are well tolerated in both Japanese and Caucasian men as well as to understand how the body absorbs and removes the study drug after being injected or infused into the body.