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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: inclacumab

• 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

Study Timeline

• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-21
• Study Start: 2013-06
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

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