The purpose of this study is to evaluate the PK and safety of ublituximab SC at different sites of administration and relative bioavailability of ublituximab SC with an AI device versus syringe.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
Administered as an SC injection by a syringe.
Administered as an SC injection by AI device.
Ublituximab will be administered as an SC injection by AI device.
Part 2: Area under the curve (AUC) From Week 0 to Week 12 [AUC(0-W12)] of Ublituximab
Time frame: Up to Week 12
Part 1: Plasma Concentrations of Ublituximab
Time frame: Up to Week 24
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Week 120
Part 2: Percentage of Participants Reporting Their Level of Satisfaction With the SC Method of Administration of Ublituximab, Assessed by Therapy Administration Satisfaction Questionnaire-Subcutaneous (TASQ-SC)
Time frame: Up to Week 96
Part 2 : Minimum Plasma Concentration (Cmin) of Ublituximab
Time frame: Up to Week 12
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