A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers

An Open-label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers

This open-label, parallel group study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy volunteers compared to Caucasian healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.

Inclusion Criteria:

• Healthy male and female volunteers, 18 to 55 years of age, inclusive Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination
• Japanese subjects must have Japanese parents and grandparents who were born in Japan
• Caucasian subjects must have Caucasian parents and grandparents
• Body mass index (BMI) 18 - 30 kg/m2 inclusive

Exclusion Criteria:

• Clinically significant abnormalities in laboratory test results (including positive test for HIV, hepatitis B and/or C), vital signs or ECGs
• Any confirmed significant allergic reactions against any drug, or multiple allergies (non-active hay fever is acceptable)
• Smokes more than 5 cigarettes per day during the three months prior to study conduct
• Participation in an investigational drug or device study within 30 days or 5 half-lives prior to screening
• Positive test for drugs of abuse
• Any suspicion of or history of alcohol and/or other substance abuse or addiction
• Pregnant or lactating women