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

BioInvent International

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: MLDL1278A

Study type

Interventional

Funder types

Industry

Identifiers

NCT01486823

11-BI-204-02

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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;