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Completed

NCT Number: NCT00822835

Study Evaluating Single Doses of ILV-095 in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy subjects.

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Philadelphia, Pennsylvania, 19148, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men and women of non-childbearing potential ages 18 to 50 years old.
  • Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to50 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, fever, active infection, or diarrhea) within 7 days before enrollment.

Treatment and study plan

ILV-095

Biological

Placebo

Biological

Primary outcomes

  1. Safety and tolerability will be evaluated from adverse events, physical examinations, vital sign measurements, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results.

    Time frame: 3 weeks per group

Secondary outcomes

  1. Pharmacokinetic parameters

    Time frame: 3 weeks per group

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study title

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Subjects

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 14, 2009
Registry last updated
Sep 18, 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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