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Study of the Safety, Tolerability, Pharmacokinetics and Pharmcodynamics of ILV-094 in Healthy Subjects

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Wyeth

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: ILV-094

Study type

Interventional

Funder types

Industry

Identifiers

NCT00447681
3199K1-100

Details and patient eligibility

About

This a randomized, double-blind placebo-controlled inpatient/outpatient, sequential group study of ascending single IV doses of ILV-094, an investigational drug, administered to healthy subjects. In addition, there will be one sub-cutaneous dose cohort, which will follow the 25 mg IV dose.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

  • Healthy subjects (Men or women of nonchildbearing potential ), aged 18 to 50 years.
  • Body mass index in the range of 18 to 30 Kg/m2 and body weight greater than 50 Kg.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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