Study of the Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of ILV-094 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00447681
First received: March 13, 2007
Last updated: December 11, 2007
Last verified: December 2007
  Purpose

This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group study of ascending single IV doses of ILV-094, an investigational drug, administered to healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow the 25 mg IV dose.


Condition Intervention Phase
Healthy
Drug: ILV-094
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetiks, and Pharmacodynamics of ILV-094 Administered Intravenously and One Dose of ILV-094 Administered Subcutaneously to Healthy Subjects

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To evaluate the safety, tolerability, pharmacokinetics and pharmcodynamics

Estimated Enrollment: 56
Study Start Date: December 2006
Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • Healthy subjects (Men or women of nonchildbearing potential ), aged 18 to 50 years.
  • Body mass index in the range of 18 to 30 Kg/m2 and body weight greater than 50 Kg.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447681

Locations
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19148
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00447681     History of Changes
Other Study ID Numbers: 3199K1-100
Study First Received: March 13, 2007
Last Updated: December 11, 2007
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 29, 2014