Study Evaluating IMA-026 in Healthy Subjects - Full Text View

Purpose

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

Condition	Intervention	Phase
Healthy	Biological: IMA-026	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study

Official Title:	Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IMA-026 Administered Subcutaneously or Intravenously to Healthy Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

Pharmacokinetic (PK) analysis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	September 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Intervention Details:

SC and IV ascending single doses from lyophilized dosage form 0.3, 1, 2, 4 mg/kg SC and 3 mg/kg IV

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517348

Locations


United States, Texas

	San Antonio, Texas, United States, 78217

Sponsors and Collaborators

Wyeth

Investigators


Study Director:	Medical Monitor	Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3192K1-1000
First Received:	August 14, 2007
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00517348
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

Adult

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00517348