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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)

NCT07503873 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-03-31

No results posted yet for this study

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 with an AI device versus syringe.

Conditions

Interventions

DRUG

Ublituximab

Administered as an SC injection by a syringe.

DRUG

Ublituximab

Administered as an SC injection by AI device.

DEVICE

AI Device

Ublituximab will be administered as an SC injection by AI device.

Sponsors & Collaborators

  • TG Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-21
Primary Completion
2027-07-31
Completion
2029-05-30
FDA Drug
Yes
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07503873 on ClinicalTrials.gov