NCT05188378

A Study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

A Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Two Subcutaneous Injection Formulations of Tocilizumab (CT-P47 and EU-approved RoActemra) in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A study to Compare the Pharmacokinetics and Safety of CT-P47 and RoActemra in Healthy Subjects

Detailed description

Subjects will be randomized in a 1:1 ratio to receive a single dose (162 mg) of either CT-P47 or EU-approved RoActemra.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	CT-P47	162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)
BIOLOGICAL	EU-approved RoActemra,	162 mg in 0.9 mL, a single subcutaneous (SC) injection via pre-filled syringe (PFS)

Timeline

• Start date: 2021-12-22
• Primary completion: 2022-10-01
• Completion: 2023-01-31
• First posted: 2022-01-12
• Last updated: 2022-01-12

Locations

1 site across 1 country: South Korea