NCT03970824

To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects

A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 312 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) in Healthy Subjects

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	CT-P17	40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
BIOLOGICAL	US-licensed Humira	40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
BIOLOGICAL	EU-approved Humira	40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS

Timeline

• Start date: 2019-05-31
• Primary completion: 2019-11-13
• Completion: 2020-01-15
• First posted: 2019-06-03
• Last updated: 2021-11-18
• Results posted: 2020-12-11

Locations

9 sites across 1 country: South Korea