Study Evaluating IMA-026 in Healthy Japanese Males

Wyeth is now a wholly owned subsidiary of Pfizer50 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

IMA-026DRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Toshima-ku, Tokyo, Japan

Outcomes

Primary Outcomes

To assess the safety and PK profile of IMA-026 administered as single ascending subcutaneous or intravenous doses.

Time frame: 6 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.