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

Wyeth is now a wholly owned subsidiary of Pfizer56 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

ILV-094DRUG

Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Ikebukuro, Tokyo, Japan

Outcomes

Primary Outcomes

To provide safety, tolerability, PK and immunogenicity profiles

Time frame: 1 year

Data from ClinicalTrials.gov

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