Study Evaluating IMA-026 in Healthy Japanese Males

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IMA-026

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528099

3192K1-1001

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind