Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02306629
Recruitment Status : Completed
First Posted : December 3, 2014
Last Update Posted : May 12, 2015
Sponsor:
Collaborators:
Pharmaceutical Research Associates
Richmond Pharmacology Limited
ACM Global Laboratories
Eurofins
The Doctors Laboratory
Information provided by (Responsible Party):
UCB Pharma ( UCB Biopharma S.P.R.L. )

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Epratuzumab sc Biological: Epratuzumab iv Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. Maximum observed plasma concentration (Cmax) [ Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study) ]
  4. Absolute bioavailability of the tested single sc doses [ Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study) ]

Secondary Outcome Measures :
  1. Time of observed Cmax (tmax) [ Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study) ]
  2. Apparent terminal half-life (t½) [ Time Frame: From Baseline (Day 1 pre-dose) to Day 85 (End of study) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02306629


Locations
Layout table for location information
United Kingdom
01
London, United Kingdom
Sponsors and Collaborators
UCB Biopharma S.P.R.L.
Pharmaceutical Research Associates
Richmond Pharmacology Limited
ACM Global Laboratories
Eurofins
The Doctors Laboratory
Investigators
Layout table for investigator information
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
Layout table for additonal information
Responsible Party: UCB Biopharma S.P.R.L.
ClinicalTrials.gov Identifier: NCT02306629    
Other Study ID Numbers: SL0032
2014-000911-15 ( EudraCT Number )
First Posted: December 3, 2014    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015
Keywords provided by UCB Pharma ( UCB Biopharma S.P.R.L. ):
Systemic Lupus Erythematosus
Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Epratuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents