Study Evaluating IMA-026 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00517348
First received: August 14, 2007
Last updated: June 24, 2009
Last verified: June 2009

August 14, 2007
June 24, 2009
September 2007
July 2008   (final data collection date for primary outcome measure)
Pharmacokinetic (PK) analysis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Pharmacokinetic (PK) analysis
Complete list of historical versions of study NCT00517348 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study Evaluating IMA-026 in Healthy Subjects
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Healthy
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
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
July 2008
July 2008   (final data collection date for primary outcome measure)
  • 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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00517348
3192K1-1000
No
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
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP