Study Evaluating Single Doses of ILV-095 in Healthy Subjects
NCT00822835
ABOUT THIS STUDY
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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.
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.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating Single Doses of ILV-095 in Healthy Subjects | |||
Official Title ICMJE | Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-095 Administered Subcutaneously to Healthy Subjects | |||
Brief Summary | The purpose of this study is to evaluate the safety and tolerability of single doses of ILV-095 in healthy subjects. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Healthy Subjects | |||
Intervention ICMJE |
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Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE | 48 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | August 2009 | |||
Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00822835 | |||
Other Study ID Numbers ICMJE | 3226K1-1000 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | September 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |