NCT01815827
Completed
Phase 1
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
Overview
- Phase
- Phase 1
- Intervention
- inclacumab
- Conditions
- Healthy Volunteer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 62
- Primary Endpoint
- Pharmacokinetics: Area under the concentration-time curve (AUC)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Caucasian Healthy volunteers
Intervention: inclacumab
Japanese Healthy volunteers
Intervention: inclacumab
Outcomes
Primary Outcomes
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time Frame: up to 197 days
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time Frame: up to 197 days
Secondary Outcomes
- 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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