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

Celltrion Healthcare

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Biological: US-licensed Xolair

Biological: EU-approved Xolair

Biological: CT-P39

Study type

Interventional

Funder types

Industry

Identifiers

NCT04018313

CT-P39 1.1

Details and patient eligibility

About

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

Enrollment

176 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy subject (male or female) between the ages of 18 and 55 years.
Subject with a body weight of > 40 kg and ≤ 90 kg and a BMI between 18.0 kg/m2 and 32.0 kg/m2(both inclusive).
Subject with a total IgE level of ≤ 100 IU/mL.

Exclusion criteria

Subject has a medical history and/or current presence of disease including one or more of the allergic reaction.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

176 participants in 5 patient groups

CT-P39 (Part 1)

Experimental group

Description: