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 |
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.
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
We found this trial at
1
site
Click here to add this to my saved trials