Healthy
Conditions
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 subcutaneous administration will be determined.
Interventions
DRUGMLDL1278A
Single intravenous dose of 360 mg MLDL1278A followed by a single subcutaneous dose of 360 mg MLDL1278A.
Sponsors
Genentech, Inc.
BioInvent International AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) of MLDL1278A. | Up to 70 days post administration. |
Secondary
| 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. |
Countries
United Kingdom
Outcome results
None listed