Study Evaluating Single Doses of ILV-095 in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Subjects
- Interventions
- Biological: ILV-095Biological: Placebo
- Registration Number
- NCT00822835
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Healthy men and women of non-childbearing potential ages 18 to 50 years old.
- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to50 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, fever, active infection, or diarrhea) within 7 days before enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ILV-095 ILV-095 6 SC single dose injections Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pharmacokinetic parameters 3 weeks per group