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Clinical trial

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

NCT04018313 is registered in ClinicalTrials.gov with Celltrion as lead sponsor.

NCT NCT04018313
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Registry record

As filed in ClinicalTrials.gov.

Title
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
Lead sponsor
Celltrion
Phase
Phase 1
Overall status
Completed
Start date
May 28, 2020
Completion date
April 30, 2021
Enrollment
176 (actual)
Sites
2

Conditions

As the registry lists them; a condition with its own page is linked.

healthy