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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: inclacumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caucasian Healthy volunteers<br> | Drug: inclacumab<br>* single intravenous doses<br>|
| Experimental: Japanese Healthy volunteers<br> | Drug: inclacumab<br>* single intravenous doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Area under the concentration-time curve (AUC) |  | up to 197 days | 
| Pharmacokinetics: Maximum plasma concentration (Cmax) |  | up to 197 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: Blood platelet leukocytes aggregation (PLA) |  | up to 197 days | 
| Pharmacodynamics: Plasma (free and total) soluble P-selectin |  | up to 197 days | 
| Safety: Incidence of adverse events |  | approximately 10 months |