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 administered with a prefilled pen 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 prefilled pen.
Ublituximab will be administered as an SC injection by prefilled pen.
TG Therapeutics Investigational Trial Site
Bihać, Bosnia and Herzegovina
RECRUITINGTG Therapeutics Investigational Trial Site
Sarajevo, Bosnia and Herzegovina
RECRUITINGTG Therapeutics Investigational Trial Site
Tuzla, Bosnia and Herzegovina
RECRUITINGTG Therapeutics Investigational Trial Site
Zenica, Bosnia and Herzegovina
Part 2: Area under the curve (AUC) at Steady State [AUCss] 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 at steady state (Cminss) of Ublituximab
Time frame: pre-dose and at multiple timepoints post-dose up to Week 120
Maximum Plasma Concentration at steady state (Cmaxss) of Ublituximab
Time frame: pre-dose and at multiple timepoints post-dose up to Week 120
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TG Therapeutics Investigational Trial Site
Tbilisi, Georgia
RECRUITINGTG Therapeutics Investigational Trial Site
Tbilisi, Georgia
RECRUITINGTG Therapeutics Investigational Trial Site
Tbilisi, Georgia
RECRUITINGTG Therapeutics Investigational Trial Site
Tbilisi, Georgia
RECRUITINGTG Therapeutics Investigational Trial Site
Shtip, North Macedonia
RECRUITINGTG Therapeutics Investigational Trial Site
Skopje, North Macedonia
RECRUITING...and 29 more locations