drugset / Trial / NCT03551275
Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple Sclerosis
Non-randomizedFactorialOpen-labelOther
Summary
BCD-132 is a humanized monoclonal antibody against CD20. BCD-132-1 is a Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients with Relapsing-Remitting Multiple Sclerosis.
Timeline
- Start
- 2018-02-22
- Primary completion
- 2018-10-18
- Completion
- 2019-03-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCD-132 | Monoclonal antibody | 50 mg | Intravenous |
| Subject | BCD-132 | Monoclonal antibody | 100 mg | Intravenous |
| Subject | BCD-132 | Monoclonal antibody | 125 mg | Intravenous |
| Subject | BCD-132 | Monoclonal antibody | 250 mg | Intravenous |
| Subject | BCD-132 | Monoclonal antibody | 500 mg | Intravenous |
| Subject | BCD-132 | Monoclonal antibody | 1000 mg | Intravenous |