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Study Evaluating IMA-026 in Healthy Japanese Males

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00528099
First received: September 10, 2007
Last updated: July 22, 2009
Last verified: July 2009

September 10, 2007
July 22, 2009
October 2007
November 2008   (final data collection date for primary outcome measure)
To assess the safety and PK profile of IMA-026 administered as single ascending subcutaneous or intravenous doses. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
To assess the safety and PK profile of IMA-026 administered as single ascending subcutaneous or intravenous doses.
Complete list of historical versions of study NCT00528099 on ClinicalTrials.gov Archive Site
Not Provided
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Study Evaluating IMA-026 in Healthy Japanese Males
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Japanese Male Subjects

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending, single subcutaneous or intravenous doses of IMA-026 in healthy Japanese male subjects

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy
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
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
50
November 2008
November 2008   (final data collection date for primary outcome measure)

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.
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00528099
3192K1-1001
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