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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-02-29

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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ILV-094

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes