Healthy Subjects
Conditions
Brief summary
The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy subjects.
Interventions
BIOLOGICALILV-095
BIOLOGICALPlacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy men and women of non-childbearing potential ages 18 to 50 years old. 2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to50 kg. 3. Healthy as determined by the investigator on the basis of screening evaluations. 4. 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. 5. Have a high probability for compliance with and completion of the study.
Exclusion criteria
1. Presence or history of any disorder that may prevent the successful completion of the study. 2. 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. 3. Acute disease state (eg, nausea, vomiting, fever, active infection, or diarrhea) within 7 days before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be evaluated from adverse events, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results. | 3 weeks per group |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters | 3 weeks per group |
Countries
United States
Outcome results
None listed