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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Biological: ILV-095; Other: Placebo

• Registration Number: NCT00822484
• 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 Japanese male subjects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-01-13
• Study First Submitted QC: 2009-01-13
• Study First Posted: 2009-01-14
• Study Start: 2009-02
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-04
• Last Update Posted: 2011-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

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 the reported AEs including any injection-site reactions, 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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Tokyo, Japan