Status:
COMPLETED
Bioavailability Study of MLDL1278A After Subcutaneous and Intravenous Administration in Healthy Subjects
Lead Sponsor:
BioInvent International AB
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01486823
Start Date
November 1 2011
End Date
July 1 2012
Last Update
December 11 2012
Active Locations (1)
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1
Quintiles Drug Research Unit at Guy's Hospital
London, United Kingdom, SE1 1YHR