The primary objective of Parts 1 and 2 is to evaluate the safety and tolerability of either single-ascending intravenous (IV) doses or a single subcutaneous (SC) dose of BIIB059 (litifilimab) in healthy volunteers (HV), and a single IV dose in participants with Systemic Lupus Erythematosus (SLE). The primary objective of Part 3 is to evaluate the safety and tolerability of multiple SC doses of BIIB059 in healthy volunteers and in participants with SLE. Secondary objectives of Parts 1 and 2 are as follows: To estimate the PK parameters of single-ascending IV doses of BIIB059 in healthy volunteers and a single IV dose of BIIB059 in participants with SLE; To estimate the PK parameters and bioavailability (F) of a single SC dose of BIIB059 in healthy volunteers; To evaluate the immunogenicity of BIIB059 administered to healthy volunteers and participants with SLE. Secondary objectives of Part 3 are as follows: To estimate the PK parameters of multiple SC doses of BIIB059 in healthy volunteers and in participants with SLE; To evaluate the immunogenicity of BIIB059 administered SC to healthy volunteers and participants with SLE.
Part 1 (single ascending dose in healthy volunteers) has closed to enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
109
See Arm Descriptions
See Arm Descriptions
Research Site
Anniston, Alabama, United States
Research Site
Birmingham, Alabama, United States
Research Site
Orlando, Florida, United States
Research Site
Great Neck, New York, United States
Research Site
Duncansville, Pennsylvania, United States
Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to Week 32
Area Under the Concentration-Time Curve from Time 0 Extrapolated to Infinity (AUCinf) of BIIB059
Time frame: Up to Week 32
Maximum Observed Concentration (Cmax) of BIIB059
Time frame: Up to Week 32
Time to Reach Maximum Observed Concentration (Tmax) of BIIB059
Time frame: Up to Week 32
Terminal Elimination Half-Life (t1/2) of BIIB059
Time frame: Up to Week 32
Clearance (CL) of BIIB059
Time frame: Up to Week 32
Apparent Clearance (CL/F) of BIIB059
For SC cohorts only
Time frame: Up to Week 32
Volume of Distribution (Vss) of BIIB059
Time frame: Up to Week 32
Apparent Volume of Distribution (Vz/F) of BIIB059
For SC cohorts only
Time frame: Up to Week 32
Bioavailability (F) for a single SC dose of BIIB059
Time frame: Up to Week 32
Absorption Rate Profile for a Single SC Dose of BIIB059
Time frame: Up to Week 32
Number of Participants Who Develop Serum Anti-BIIB059 Antibodies
Time frame: Up to Week 32
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