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Study Evaluating IMA-026 in Healthy Japanese Males

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ClinicalTrials.gov Identifier: NCT00528099
Recruitment Status : Completed
First Posted : September 12, 2007
Last Update Posted : July 23, 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 ascending, single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 Japanese Male Subjects
Study Start Date : October 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Intervention Details:
  • Drug: 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. To assess the safety and PK profile of IMA-026 administered as single ascending subcutaneous or intravenous doses. [ Time Frame: 6 months ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men ages 20 to 40 years, inclusive, at screening
  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight > 45 kg
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vitals signs, and 12 lead ECG.

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): NCT00528099


Locations
Japan
Toshima-ku, Tokyo, Japan, 171-0014
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: NCT00528099     History of Changes
Other Study ID Numbers: 3192K1-1001
First Posted: September 12, 2007    Key Record Dates
Last Update Posted: July 23, 2009
Last Verified: July 2009