A Safety and Pharmacokinetics Study of CNTO 3157 in Healthy Japanese and Caucasian Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): 100 mg CNTO 3157; 300 mg CNTO 3157; 600 mg CNTO 3157; 300 mg CNTO 3157; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Drug
Intervention description(s): A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157; 2 SC injections of CNTO 3157 providing a total dose of 300 mg; 4 SC injections of CNTO 3157 providing a total dose of 600 mg; 300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes; SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; CNTO 3157; Pharmacokinetics