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Study Evaluating IMA-026 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT00517348
Recruitment Status : Completed
First Posted : August 16, 2007
Last Update Posted : June 25, 2009
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of IMA-026 administered subcutaneously (SC) or intravenously (IV) in healthy adults.

Condition or disease Intervention/treatment Phase
Healthy Biological: IMA-026 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Subjects
Study Start Date : September 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Intervention Details:
    Biological: IMA-026
    SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV


Primary Outcome Measures :
  1. Pharmacokinetic (PK) analysis [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • Healthy men and women ages 18 - 50
  • Body weight greater than or equal to 50 kilograms
  • Nonsmoker or fewer than 10 cigarettes per day
  • No serious infection, i.e., requiring hospitalization or IV antibiotics, or an upper respiratory infection within 1 month before dosing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517348


Locations
United States, Texas
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00517348     History of Changes
Other Study ID Numbers: 3192K1-1000
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: June 25, 2009
Last Verified: June 2009

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Adult