NCT04018313

To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 176 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	CT-P39	150 mg/mL, Solution for injection in PFS
BIOLOGICAL	EU-approved Xolair	150 mg/mL, Solution for injection in PFS
BIOLOGICAL	CT-P39	150 mg/mL, Solution for injection in PFS
BIOLOGICAL	EU-approved Xolair	150 mg/mL, Solution for injection in PFS
BIOLOGICAL	US-licensed Xolair	150 mg/mL, Solution for injection in PFS

Timeline

• Start date: 2020-05-28
• Primary completion: 2021-03-27
• Completion: 2021-04-30
• First posted: 2019-07-12
• Last updated: 2023-05-11
• Results posted: 2023-05-11

Locations

2 sites across 1 country: Australia