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