Completed

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

What is being tested

inclacumab

+ inclacumab

Drug

Who is being recruted

From 18 to 55 Years

+11 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Phase 1

Interventional

Study Start: June 2013

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: November 2, 2016

Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01815827

Principal SponsorHoffmann-La Roche

Last updated: November 2, 2016

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

62 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

Body mass index (BMI) 18 - 30 kg/m2 inclusive

Caucasian subjects must have Caucasian parents and grandparents

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

7 exclusion criteria prevent from participating

Any confirmed significant allergic reactions against any drug, or multiple allergies (non-active hay fever is acceptable)

Any suspicion of or history of alcohol and/or other substance abuse or addiction

Clinically significant abnormalities in laboratory test results (including positive test for HIV, hepatitis B and/or C), vital signs or ECGs

Participation in an investigational drug or device study within 30 days or 5 half-lives prior to screening

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Anaheim, United StatesOpen in Google Maps

CompletedOne Study Center