WHO ICTRP trial
A study to evaluate to compare the pharmacokinetic, pharmacodynamics, safety and…
CTRI/2024/09/073894 · Clinical Trials Registry India (CTRI) · Not Recruiting
Key facts
| Trial ID | CTRI/2024/09/073894 |
|---|---|
| Public title | A study to evaluate to compare the pharmacokinetic, pharmacodynamics, safety and immunogenicity for three formulations of Tocilizumab |
| Scientific title | A randomized phase 1, double-blind, single dose, three-arm, parallel group comparative Pharmacokinetic, Pharmacodynamic, safety, and immunogenicity assessment of BP08 (Tocilizumab) versus US licensed Actemra® and EU approved RoActemra® administration through the Intravenous infusion route in healthy… |
| Primary sponsor | CuraTeQ Biologics Private Ltd. |
| Registry | Clinical Trials Registry India (CTRI) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | Phase 1 |
| Countries | India |
| Interventions | Intervention1: BP08 (Tocilizumab): 400 mg (20 mg/mL) injection, Duration: Single Dose Intravenous infusion of 4 mg/kg in 60 minutes Control Intervention1: ACTEMRA® (Tocilizumab): 400 mg (20 mg/mL) injection, Duration: Single Dose… |
| Registration date | Sep 13, 2024 |
| Target size | 114 |
| Secondary IDs | 23-VIN-0347 Version No. 01 dated 16 Aug 2023 |
| Registry page | ctri.nic.in |
At a glance
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: