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



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2016
Start Date:June 2013
End Date:February 2014

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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
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