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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01815827

Enrollment

Registered

2013-03-21

Start date

2013-06-30

Completion date

2014-02-28

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Brief summary

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.

Interventions

DRUGinclacumab

single intravenous doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026