Study Evaluating Single Doses of ILV-095 in Healthy Japanese Male Subjects

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Japanese Male Subjects

The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy Japanese male subjects.

Inclusion Criteria:

• Men aged 20 to 45 years inclusive at screening. Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after study drug administration.
• Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight greater than or equal to 45 kg.
• Healthy as determined by the investigator on the basis of screening evaluations.
• Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
• Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

• Presence or history of any disorder that may prevent the successful completion of the study.
• Any subject who had orthopedic surgery within 12 weeks of the screening visit or has planned (elective) orthopedic surgery within 12 weeks of study drug administration.
• Acute disease state (eg, nausea, vomiting, infection, fever, active infection, or diarrhea) within 7 days before enrollment.