drugset / Trial / NCT05974969
A Study to Assess the PK, PD, Safety and Immunogenicity of Single IV Infusion of BCD-264 and Darzalex in Healthy Subjects
RandomizedParallel-groupQuadruple-blindOther
Summary
The goal of this clinical study is to establish the comparability of the pharmacokinetics and similarity of the safety, immunogenicity and pharmacodynamic profiles of BCD-264 and Darzalex following a single intravenous infusion in healthy subjects.
Timeline
- Start
- 2023-05-17
- Primary completion
- 2023-08-15
- Completion
- 2023-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BCD-264 | Unknown | 8 mg/kg | Intravenous |
| Comparator | Daratumumab | Monoclonal antibody | 8 mg/kg | Intravenous |
Indications
No indication recorded.