A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
- Registration Number
- NCT01815827
- Lead Sponsor
- Hoffmann-La Roche
- 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 healthy volunteers. Subjects will receive a single intravenous dose of inclacumab. Follow-up will be for up to 197 days.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Japanese Healthy volunteers inclacumab - Caucasian Healthy volunteers inclacumab -
- Primary Outcome Measures
Name Time Method Pharmacokinetics: Area under the concentration-time curve (AUC) up to 197 days Pharmacokinetics: Maximum plasma concentration (Cmax) up to 197 days
- Secondary Outcome Measures
Name Time Method Pharmacodynamics: Plasma (free and total) soluble P-selectin up to 197 days Pharmacodynamics: Blood platelet leukocytes aggregation (PLA) up to 197 days Safety: Incidence of adverse events approximately 10 months
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