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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486823
First Posted: December 7, 2011
Last Update Posted: December 11, 2012
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.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
BioInvent International AB
  Purpose
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 Intervention Phase
Healthy Drug: MLDL1278A Phase 1

Study Type: Interventional
Study Design: 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

Further study details as provided by BioInvent International AB:

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

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

Enrollment: 22
Study Start Date: November 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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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;
  Contacts and Locations
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.
  More Information

Responsible Party: BioInvent International AB
ClinicalTrials.gov Identifier: NCT01486823     History of Changes
Other Study ID Numbers: 11-BI-204-02
First Submitted: November 22, 2011
First Posted: December 7, 2011
Last Update Posted: December 11, 2012
Last Verified: December 2012

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