A Randomized, Double-blind, Parallel-group Study to Compare the Pharmacokinetics, Efficacy, Pharmacodynamics, Safety, and Immunogenicity of CYB704 (Proposed Ocrelizumab Biosimilar) and Ocrevus® in Participants With Relapsing Multiple Sclerosis (RMS) [STRIVE-MS].

Summary

The goal of this clinical trial is to learn if drug CYB704, a proposed biosimilar to Ocrevus, works to treat multiple sclerosis in the same way as the reference product Ocrevus(R). The main questions it aims to answer are: * Is CYB704 distributed in the body in the same way as the reference product (demonstration of pharmacokinetic (PK) similarity)? * Does have CYB704 the same treatment effect and side effects as the reference product? Researchers will compare CYB704 to a Ocrevus (Ocrevus-US and Ocrevus-EU). Participants will: * Take drug CYB704 or Ocrevus (Ocrevus-US and Ocrevus-EU) * Visit the clinic for at least 15 treatment visits, checkups and tests * Will undergo regular magnetic resonance imaging (MRI) examinations

Eligibility

Age range

18–55 years

Sex

All

Healthy volunteers

No

Interventions

• Biological
  CYB704

  Intravenous Infusion

• Biological
  Ocrevus-EU

  Intravenous Infusion

• Biological
  Ocrevus-US

  Intravenous Infusion

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