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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Biological: EU-approved Xolair; Biological: CT-P39; Biological: US-licensed Xolair

• Registration Number: NCT04018313
• Lead Sponsor: Celltrion

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-12
• Study Start: 2020-05-28
• Primary Completion: 2021-03-27
• Study Completion: 2021-04-30
• Status Verified: 2021-09
• Results First Submitted: 2022-06-30
• Results First Submitted QC: 2022-06-30
• Last Update Submitted: 2022-06-30
• Results First Posted: 2023-05-11
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EU-approved Xolair (Part 2)	EU-approved Xolair	150 mg/mL, Solution for injection in PFS
CT-P39 (Part 1)	CT-P39	150 mg/mL, Solution for injection in PFS
CT-P39 (Part 2)	CT-P39	150 mg/mL, Solution for injection in PFS
EU-approved Xolair (Part 1)	EU-approved Xolair	150 mg/mL, Solution for injection in PFS
US-licensed Xolair (Part 2)	US-licensed Xolair	150 mg/mL, Solution for injection in PFS

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2	up to day 127	Area Under the concentration-time Curve from time zero to infinity (AUC0-inf) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Pharmacokinetic Outcome Measures [Cmax] for Part 2	up to day 127	Maximum serum concentration (Cmax) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)
Pharmacokinetic Outcome Measures [AUC0-last] for Part 2	up to day 127	Area Under the concentration-time Curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects (CT-P39 to EU-approved Xolair, CT-P39 to US-licensed Xolair, and EU-approved Xolair to US-licensed Xolair)

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamic Outcome Measures [Tmin of Free IgE] for Part 1 & Part 2	Up to day 127	To assess the Time to Cmin (Tmin) of Free IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2	up to day 127	To assess Time to Cmax (Tmax) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Pharmacodynamics Outcome Measures [Cmin of Free IgE] for Part 1 & Part 2	up to day 127	To assess the minimum observed concentration (Cmin) of Free IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2	up to day 127	To assess the Time to Cmax (Tmax) of total IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2	up to day 127	To assess Terminal half-life (t1/2) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2	up to day 127	To assess the maximum observed concentration (Cmax) of total IgE in CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects

Trial Locations

Locations (1)

Phase 1 unit; 🇦🇺 Adelaide, South Australia, Australia