Study Evaluating Single Doses of ILV-095 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00822835
First received: January 13, 2009
Last updated: September 17, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Healthy Subjects
Biological: ILV-095
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Subjects

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacokinetic parameters [ Time Frame: 3 weeks per group ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ILV-095
6 SC single dose injections
Biological: ILV-095
Placebo Comparator: Placebo
Placebo
Biological: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy men and women of non-childbearing potential ages 18 to 50 years old.
  2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to50 kg.
  3. Healthy as determined by the investigator on the basis of screening evaluations.
  4. 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.
  5. Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

  1. Presence or history of any disorder that may prevent the successful completion of the study.
  2. 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.
  3. Acute disease state (eg, nausea, vomiting, fever, active infection, or diarrhea) within 7 days before enrollment.
  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: NCT00822835

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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00822835     History of Changes
Other Study ID Numbers: 3226K1-1000
Study First Received: January 13, 2009
Last Updated: September 17, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on August 28, 2014