MedDataX Logo

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

NCT ID: NCT01815827

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Caucasian Healthy volunteers

Group Type ACTIVE_COMPARATOR

inclacumab

Intervention Type DRUG

single intravenous doses

Japanese Healthy volunteers

Group Type EXPERIMENTAL

inclacumab

Intervention Type DRUG

single intravenous doses

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

inclacumab

single intravenous doses

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anaheim, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Morrison M, Palermo G, Schmitt C. Lack of ethnic differences in the pharmacokinetics and pharmacodynamics of inclacumab in healthy Japanese and Caucasian subjects. Eur J Clin Pharmacol. 2015 Nov;71(11):1365-74. doi: 10.1007/s00228-015-1938-4. Epub 2015 Sep 12.

Reference Type DERIVED
PMID: 26363899 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BP28134

Identifier Type: -

Identifier Source: org_study_id