Philadelphia, Pennsylvania, 19148, United States
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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Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
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
BiologicalPlacebo
BiologicalPrimary outcomes
-
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
-
Pharmacokinetic parameters
Time frame: 3 weeks per group
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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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