Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects

Wyeth

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ILV-094

Study type

Interventional

Funder types

Industry

Identifiers

NCT00434746

3199K1-1102

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 estimated patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.