Status:
COMPLETED
Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy
Eligibility:
MALE
20-40 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00434746
Start Date
January 1 2007
End Date
February 1 2008
Last Update
July 10 2009
Active Locations (1)
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1
Ikebukuro, Tokyo, Japan, 171-0014