Status:
COMPLETED
A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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 h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01815827
Start Date
June 1 2013
End Date
February 1 2014
Last Update
November 2 2016
Active Locations (1)
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1
Anaheim, California, United States, 92801