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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: MLDL1278A; Drug: MLDL1278A

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 1YHR
    • Quintiles Drug Research Unit at Guy's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort B	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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration versus time curve (AUC) of MLDL1278A.	Up to 70 days post administration.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BioInvent International AB
• Collaborators: Genentech, Inc.
• Investigators: Principal Investigator: Darren Wilbraham, MD, Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: November 22, 2011
• First Submitted That Met QC Criteria: December 6, 2011
• First Posted (Estimate): December 7, 2011

Study Record Updates

• Last Update Posted (Estimate): December 11, 2012
• Last Update Submitted That Met QC Criteria: December 10, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: 11-BI-204-02