Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy
- Registration Number
- NCT00434746
- Lead Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Brief Summary
The purpose of this study is to assess the safety and tolerability of ascending single IV doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.
- Detailed Description
This is a randomized, double-blind, placebo-controlled, inpatient/outpatient, sequential-group study of ascending single IV doses of ILV-094 administered to healthy Japanese male subjects.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
- Men aged 20 to 45 years inclusive at screening.
- Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight>45.
- Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking during inpatient stay.
- Healthy as determined by the investigator on the basis of screening evaluation.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To provide safety, tolerability, PK and immunogenicity profiles 1 year
- Secondary Outcome Measures
Name Time Method