NCT05617183

Compare the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

A Phase 1, Randomized, Open-label, Two-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P47 in Healthy Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 268 (estimated)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1 study to compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled syringe of CT-P47 in Healthy Subjects.

Detailed description

CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate the pharmacokinetics and safety of the Auto-injector and Pre-filled syringe of CT-P47 in healthy subjects.

Conditions

• Healthy Subjects

Interventions

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

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-04-01
• Completion: 2023-09-01
• First posted: 2022-11-15
• Last updated: 2023-03-27

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study