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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Caucasian Healthy volunteers
Drug: inclacumab
single intravenous doses
Experimental: Japanese Healthy volunteers
Drug: inclacumab
single intravenous doses

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

March 19, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 21, 2013

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • BP28134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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