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

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Biological: ILV-095; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00822484

3226K2-1001

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

ILV-095

Active Comparator group

Description:

6 SC single dose injections

Treatment:

Biological: ILV-095

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo