Study Evaluating IMA-026 in Healthy Japanese Males

NCT ID: NCT00528099

Last Updated: 2009-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-11-30

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Wyeth

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Locations

Toshima-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

3192K1-1001

Identifier Type: -

Identifier Source: org_study_id