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

Primary Purpose

Systemic Lupus Erythematosus

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

Epratuzumab sc

Epratuzumab iv

About this trial

This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Epratuzumab dose 1 sc

Epratuzumab dose 2 sc

Epratuzumab dose 3 sc

Epratuzumab dose 2 iv

Arm Description

This group of Caucasian and Japanese subjects will receive one single dose 1 of epratuzumab subcutaneous

This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab subcutaneous

This group of Caucasian subjects will receive one single dose 3 of epratuzumab subcutaneous

This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab as an intra venous infusion

Outcomes

Primary Outcome Measures

Area under the plasma concentration time curve from Baseline to time of last detectable concentration (AUC(0-t))

Area under the plasma concentration time curve from zero up to infinity (AUC(0-inf))

Maximum observed plasma concentration (Cmax)

Absolute bioavailability of the tested single sc doses

Secondary Outcome Measures

Time of observed Cmax (tmax)

Apparent terminal half-life (t½)

Full Information

NCT ID

NCT02306629

First Posted

November 29, 2014

Last Updated

May 11, 2015

Sponsor

UCB Biopharma S.P.R.L.

Collaborators

Pharmaceutical Research Associates, Richmond Pharmacology Limited, ACM Global Laboratories, Eurofins, The Doctors Laboratory

1. Study Identification

Unique Protocol Identification Number

NCT02306629

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

UCB Biopharma S.P.R.L.

Collaborators

Pharmaceutical Research Associates, Richmond Pharmacology Limited, ACM Global Laboratories, Eurofins, The Doctors Laboratory

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epratuzumab dose 1 sc

Arm Type

Experimental

Arm Description

This group of Caucasian and Japanese subjects will receive one single dose 1 of epratuzumab subcutaneous

Arm Title

Epratuzumab dose 2 sc

Arm Type

Experimental

Arm Description

This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab subcutaneous

Arm Title

Epratuzumab dose 3 sc

Arm Type

Experimental

Arm Description

This group of Caucasian subjects will receive one single dose 3 of epratuzumab subcutaneous

Arm Title

Epratuzumab dose 2 iv

Arm Type

Active Comparator

Arm Description

This group of Caucasian and Japanese subjects will receive one single dose 2 of epratuzumab as an intra venous infusion

Intervention Type

Biological

Intervention Name(s)

Epratuzumab sc

Intervention Description

Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous,

Intervention Type

Biological

Intervention Name(s)

Epratuzumab iv

Other Intervention Name(s)

CDP3194, EMAB

Intervention Description

Active substance: Epratuzumab, Pharmaceutical form: Solution for Infusion, Route of Administration: Intravenous,

Primary Outcome Measure Information:

Title

Area under the plasma concentration time curve from Baseline to time of last detectable concentration (AUC(0-t))

Time Frame