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
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01486823

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

No publications provided

Responsible Party: BioInvent International AB
ClinicalTrials.gov Identifier: NCT01486823     History of Changes
Other Study ID Numbers: 11-BI-204-02
Study First Received: November 22, 2011
Last Updated: December 10, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on August 27, 2014