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Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects

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NCT00434746

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Ikebukuro, Tokyo, 171-0014 Japan
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men aged 20 to 45 years inclusive at screening.

- Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight>45.

- Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking
during inpatient stay.

- Healthy as determined by the investigator on the basis of screening evaluation.

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

- Men aged 20 to 45 years inclusive at screening.

- Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight>45.

- Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking
during inpatient stay.

- Healthy as determined by the investigator on the basis of screening evaluation.

NCT00434746
Pfizer
Completed
Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects

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Study of the Safety, Tolerability, PK, and PD of ILV-094 Administered IV or SC to Healthy Subjects
Ascending Multiple Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ILV-094 Administered IV and One Dose of SC Administered to Healthy Subjects
The purpose of this study is to assess the safety and tolerability of ascending single IV doses of ILV-094 (an investigational drug) and one SC dose of ILV-094 in healthy subjects.
This is a randomized, double-blind, placebo-controlled, inpatient/outpatient, sequential-group study of ascending single IV doses of ILV-094 administered to healthy Japanese male subjects.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
Drug: ILV-094
Single, ascending doses of 5, 15, 50, 100, 300, and 600 mg IV or SC dose of ILV-094 or placebo
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
February 2008
February 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men aged 20 to 45 years inclusive at screening.
  • Body mass index in the range of 17.6 to 26.4 kg/m2 and body weight>45.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day. Must be abstain from smoking during inpatient stay.
  • Healthy as determined by the investigator on the basis of screening evaluation.
Sexes Eligible for Study: Male
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00434746
3199K1-1102
Not Provided
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
July 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.

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1-800-718-1021

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[email protected]



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