A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
Completed · Phase 1
Conditions studied: Healthy Volunteer
In brief
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.
Key facts
- Study ID
- NCT01815827
- Run by
- Hoffmann-La Roche
- People needed
- 62
- Starts
- 2013-06-01
- Expected to finish
- 2014-02-01
- Last updated by the study team
- 2016-11-02
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Study site — Anaheim, California, United States
Full record on ClinicalTrials.gov
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