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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
BioInvent International AB
ClinicalTrials.gov Identifier:
NCT01486823
First received: November 22, 2011
Last updated: December 10, 2012
Last verified: December 2012

November 22, 2011
December 10, 2012
November 2011
July 2012   (final data collection date for primary outcome measure)
Area under the plasma concentration versus time curve (AUC) of MLDL1278A. [ Time Frame: Up to 70 days post administration. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01486823 on ClinicalTrials.gov Archive Site
  • Peak plasma concentration (Cmax) of MLDL1278A. [ Time Frame: Up to 70 days post administration. ] [ Designated as safety issue: No ]
  • Plasma clearance (CL) of MLDL1278A. [ Time Frame: Up to 70 days post administration. ] [ Designated as safety issue: No ]
  • Number of participants with an anti therapeutic antibody (ATA) response. [ Time Frame: Up to 140 days post administration. ] [ Designated as safety issue: No ]
  • Number of participants with adverse events. [ Time Frame: Up to 140 days post administration. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects
An Open-label, Single-dose Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Healthy
  • Drug: MLDL1278A
    Single intravenous dose of 360 mg MLDL1278A followed by a single subcutaneous dose of 360 mg MLDL1278A.
  • Drug: MLDL1278A
    Single subcutaneous dose of 360 mg MLDL1278A.
  • Experimental: Cohort A
    Intervention: Drug: MLDL1278A
  • Experimental: Cohort B
    Intervention: Drug: MLDL1278A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
July 2012
July 2012   (final data collection date for primary outcome measure)

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;
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01486823
11-BI-204-02
Yes
BioInvent International AB
BioInvent International AB
Genentech
Principal Investigator: Darren Wilbraham, MD Quintiles Ltd
BioInvent International AB
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP