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OpenTrials
Completed

NCT Number: NCT01815827

A Study of Single Dose 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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim, California, 92801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inclacumab

Drug

single intravenous doses

Primary outcomes

  1. Pharmacokinetics: Area under the concentration-time curve (AUC)

    Time frame: up to 197 days

  2. Pharmacokinetics: Maximum plasma concentration (Cmax)

    Time frame: up to 197 days

Secondary outcomes

  1. Pharmacodynamics: Blood platelet leukocytes aggregation (PLA)

    Time frame: up to 197 days

  2. Pharmacodynamics: Plasma (free and total) soluble P-selectin

    Time frame: up to 197 days

  3. Safety: Incidence of adverse events

    Time frame: approximately 10 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 21, 2013
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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