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A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Sponsor: TG Therapeutics, Inc.
Summary
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 an AI device versus syringe.
Official title: A Phase 2, Multicenter, Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector Device Versus Syringe in Patients With Multiple Sclerosis
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
350
Start Date
2026-04-01
Completion Date
2029-05-30
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Ublituximab
Administered as an SC injection by a syringe.
Ublituximab
Administered as an SC injection by AI device.
AI device
Ublituximab will be administered as an SC injection by AI device.
Locations (36)
TG Therapeutics Investigational Trial Site
Bihać, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Sarajevo, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Tuzla, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Zenica, Bosnia and Herzegovina
TG Therapeutics Investigational Trial Site
Tbilisi, Georgia
TG Therapeutics Investigational Trial Site
Tbilisi, Georgia
TG Therapeutics Investigational Trial Site
Tbilisi, Georgia
TG Therapeutics Investigational Trial Site
Tbilisi, Georgia
TG Therapeutics Investigational Trial Site
Bydgoszcz, Poland
TG Therapeutics Investigational Trial Site
Katowice, Poland
TG Therapeutics Investigational Trial Site
Kielce, Poland
TG Therapeutics Investigational Trial Site
Lodz, Poland
TG Therapeutics Investigational Trial Site
Poznan, Poland
TG Therapeutics Investigational Trial Site
Warsaw, Poland
TG Therapeutics Investigational Trial Site
Belgrade, Serbia
TG Therapeutics Investigational Trial Site
Kragujevac, Serbia
TG Therapeutics Investigational Trial Site
Chernihiv, Ukraine
TG Therapeutics Investigational Trial Site
Chernihiv, Ukraine
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, Ukraine
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, Ukraine
TG Therapeutics Investigational Trial Site
Ivano-Frankivsk, Ukraine
TG Therapeutics Investigational Trial Site
Kyiv, Ukraine
TG Therapeutics Investigational Trial Site
Kyiv, Ukraine
TG Therapeutics Investigational Trial Site
Kyiv, Ukraine
TG Therapeutics Investigational Trial Site
Kyiv, Ukraine
TG Therapeutics Investigational Trial Site
Kyiv, Ukraine
TG Therapeutics Investigational Trial Site
Kyiv, Ukraine
TG Therapeutics Investigational Trial Site
Lviv, Ukraine
TG Therapeutics Investigational Trial Site
Lviv, Ukraine
TG Therapeutics Investigational Trial Site
Odesa, Ukraine
TG Therapeutics Investigational Trial Site
Poltava, Ukraine
TG Therapeutics Investigational Trial Site
Tbilisi, Ukraine
TG Therapeutics Investigational Trial Site
Ternopil, Ukraine
TG Therapeutics Investigational Trial Site
Uzhhorod, Ukraine
TG Therapeutics Investigational Trial Site
Vinnytsia, Ukraine
TG Therapeutics Investigational Trial Site
Vinnytsia, Ukraine