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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: inclacumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01815827

BP28134

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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