We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects

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: NCT01486823
Recruitment Status : Completed
First Posted : December 7, 2011
Last Update Posted : December 11, 2012
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
BioInvent International AB

Brief Summary:
This is a study in healthy volunteers designed to investigate the PK following intravenous and subcutaneous administration of MLDL1278A (also known as BI-204). The bioavalialbility of MLDL1278A after subcutaneous administration will be determined.

Condition or disease Intervention/treatment Phase
Healthy Drug: MLDL1278A Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: An Open-label, Single-dose Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects
Study Start Date : November 2011
Primary Completion Date : July 2012
Study Completion Date : July 2012

Arm Intervention/treatment
Experimental: Cohort A Drug: MLDL1278A
Single intravenous dose of 360 mg MLDL1278A followed by a single subcutaneous dose of 360 mg MLDL1278A.
Experimental: Cohort B Drug: MLDL1278A
Single subcutaneous dose of 360 mg MLDL1278A.



Primary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) of MLDL1278A. [ Time Frame: Up to 70 days post administration. ]

Secondary Outcome Measures :
  1. Peak plasma concentration (Cmax) of MLDL1278A. [ Time Frame: Up to 70 days post administration. ]
  2. Plasma clearance (CL) of MLDL1278A. [ Time Frame: Up to 70 days post administration. ]
  3. Number of participants with an anti therapeutic antibody (ATA) response. [ Time Frame: Up to 140 days post administration. ]
  4. Number of participants with adverse events. [ Time Frame: Up to 140 days post administration. ]


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.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult males/females aged 18 to 55 years inclusive at screening;
  • Subjects who are between 18.0 and 30.0 kg/m2 body mass index (BMI) inclusive and weigh between 55.0 and 100.0 kg inclusive;

Exclusion Criteria:

  • Any clinically relevant disease or disorder (past or present), which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the study, or the subject's ability to participate in the study;
  • Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, coagulation, urinalysis, vital signs or ECG at baseline, which, in the opinion of the investigator, may put the subject at risk because of his participation in the study;

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): NCT01486823


Locations
United Kingdom
Quintiles Drug Research Unit at Guy's Hospital
London, United Kingdom, SE1 1YHR
Sponsors and Collaborators
BioInvent International AB
Genentech, Inc.
Investigators
Principal Investigator: Darren Wilbraham, MD Quintiles, Inc.

Responsible Party: BioInvent International AB
ClinicalTrials.gov Identifier: NCT01486823     History of Changes
Other Study ID Numbers: 11-BI-204-02
First Posted: December 7, 2011    Key Record Dates
Last Update Posted: December 11, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs