Study to Compare Properties of Epratuzumab When Given as an Injection Under the Skin or Directly Into the Blood

May 11, 2015 updated by: UCB Biopharma S.P.R.L.

An Open-label, Parallel-group, Single-dose Escalation Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Pharmacodynamics of Subcutaneous Epratuzumab in Healthy Caucasian and Japanese Subjects

To assess how the absolute bioavailability, dose proportionality, pharmacokinetics, safety and tolerability of epratuzumab compared when given as a subcutaneous (sc) injection as to when given as an intravenous (iv) infusion in Caucasian and Japanese healthy volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is male or female.
  • At the Screening Visit, subject is 18 years to 50 years, inclusive (for Caucasian subjects), or 20 years to 50 years (for Japanese subjects)
  • Subject must be in good health (physically and mentally) as determined by the investigator on the basis of medical history
  • Subject has a body weight of 45 kg to 90 kg, inclusive, and body mass index (BMI) between 18.0 kg/m2 and 29.9 kg/m2, inclusive
  • Japanese subjects are defined as a person carrying a Japanese passport, who is a descendant of 4 Japanese grandparents and has not been outside Japan for more than 5 years prior to screening
  • Females of childbearing potential are required to have a negative serum pregnancy test at the Screening Visit and must agree to use an acceptable method of birth control during the study and for a period of 3 months after the administration of investigational medicinal product (IMP)
  • Male subjects must agree to use an acceptable method of contraception during the study and for at least 3 months after receiving IMP unless they have undergone vasectomy

Exclusion Criteria:

  • Subject has donated blood (including through participation in another clinical study) or suffered blood loss (≥450 mL) <60 days prior to dosing, or has donated platelets <14 days prior to dosing
  • Subject has active malignancies or a history of malignancy
  • Subject has a history of severe or multiple allergies
  • Subject has a history of chronic infection, recent serious or life-threatening infection
  • Subject with a recurrent history or active systemic/respiratory infection due to fungal, parasitic, or mycotic pathogens
  • Subject has a positive HBsAg, anti-HCV or anti-HIV test result during the Screening Period
  • Subject has a history of or a concurrent clinically significant illness, medical condition, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the subject upon exposure to epratuzumab or confound the results of the study
  • Female subjects who are breast feeding, pregnant, or plan to become pregnant during the study or within 3 months following dosing of the IMP
  • Subjects who are immunocompromised
  • A confirmed positive urine drug screen
  • Subject has a history of substance abuse, drug addiction, or alcoholism within 3 years prior to study admission
  • Subject is unable or unwilling to stop smoking during the inpatient stay
  • Subject has previous exposure to, or has participated in studies with, any other anti-B-cell therapies
  • Subject has a medical condition that requires chronic medication
  • Subject has received a live vaccine in the month prior to the administration of IMP or is scheduled or expected to receive live vaccines during the study period or for 3 months after administration of the IMP

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Epratuzumab dose 1 sc
This group of Caucasian and Japanese subjects will receive one single dose 1 of epratuzumab subcutaneous
Biological: Epratuzumab sc
Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous,
Experimental: Epratuzumab dose 2 sc
This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab subcutaneous
Biological: Epratuzumab sc
Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous,
Experimental: Epratuzumab dose 3 sc
This group of Caucasian subjects will receive one single dose 3 of epratuzumab subcutaneous
Biological: Epratuzumab sc
Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous,
Active Comparator: Epratuzumab dose 2 iv
This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab as an intra venous infusion
Biological: Epratuzumab iv
Active substance: Epratuzumab, Pharmaceutical form: Solution for Infusion, Route of Administration: Intravenous,
Other Names:
  • CDP3194
  • EMAB

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Area under the plasma concentration time curve from Baseline to time of last detectable concentration (AUC(0-t))
Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Area under the plasma concentration time curve from zero up to infinity (AUC(0-inf))
Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Maximum observed plasma concentration (Cmax)
Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Absolute bioavailability of the tested single sc doses
Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
From Baseline (Day 1 pre-dose) to Day 85 (End of study)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time of observed Cmax (tmax)
Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
From Baseline (Day 1 pre-dose) to Day 85 (End of study)
Apparent terminal half-life (t½)
Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study)
From Baseline (Day 1 pre-dose) to Day 85 (End of study)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UCB Biopharma S.P.R.L.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pharmaceutical Research Associates
Richmond Pharmacology Limited
Eurofins
ACM Global Laboratories
The Doctors Laboratory

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SL0032
  • 2014-000911-15 (EudraCT Number)

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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