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Study Evaluating Single Doses of ILV-095 in Healthy Subjects

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NCT00822835

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Philadelphia, Pennsylvania, 19148 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Subjects
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-50 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT00822835
Pfizer
Completed
Study Evaluating Single Doses of ILV-095 in Healthy Subjects

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Study Evaluating Single Doses of ILV-095 in Healthy Subjects
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Subjects
The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Healthy Subjects
  • Biological: ILV-095
  • Biological: Placebo
  • Active Comparator: ILV-095
    6 SC single dose injections
    Intervention: Biological: ILV-095
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Biological: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2009
August 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00822835
3226K1-1000
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
September 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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