drugset / Trial / NCT04885829
Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers
RandomizedCrossoverQuadruple-blindTreatment
Summary
A single dose, two period trial where participants will be given either of 3 Tocilizumab product on Day 1 during period 1 and either one of the remaining 2 Tocilizumab products on Day 1 period 2. There will be at least 6 weeks (42 days) of wash out between subsequent two period dosing. The maximum flexibility allowed between subsequent periods will be up to 9 weeks (63 days). Names of the 3 tocilizumab products are DRL\_TC, RP and RMP. So if a participant receives DRL\_TC on Day 1 Period 1 then he/she will either receive RP/RMP on Day 1 Period 2.
Timeline
- Start
- 2021-05-31
- Primary completion
- 2023-05-04
- Completion
- 2023-05-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tocilizumab | Monoclonal antibody | 162 mg | Subcutaneous |