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Study Evaluating IMA-026 in Healthy Japanese Males

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Toshima-ku, Tokyo, 171-0014 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-40 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00528099
Pfizer
Completed
Study Evaluating IMA-026 in Healthy Japanese Males

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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
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Sexes Eligible for Study: Male
20 Years to 40 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00528099
3192K1-1001
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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