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OpenTrials
Completed

NCT Number: NCT00434746

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

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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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Ikebukuro, Tokyo, 171-0014, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ILV-094

Drug

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

Primary outcomes

  1. To provide safety, tolerability, PK and immunogenicity profiles

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-094 Administered IV and One Dose of SC Administered to Healthy Subjects

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2007
Registry last updated
Jul 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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