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

Study Overview
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Brief Summary
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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

Official Title
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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
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Healthy

Intervention / Treatment
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* Biological: CT-P39
* Biological: EU-approved Xolair
* Biological: CT-P39
* Biological: EU-approved Xolair
* Biological: US-licensed Xolair


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P39 (Part 1)<br>150 mg/mL, Solution for injection in PFS | Biological: CT-P39<br>* 150 mg/mL, Solution for injection in PFS<br>|
| Active Comparator: EU-approved Xolair (Part 1)<br>150 mg/mL, Solution for injection in PFS | Biological: EU-approved Xolair<br>* 150 mg/mL, Solution for injection in PFS<br>|
| Experimental: CT-P39 (Part 2)<br>150 mg/mL, Solution for injection in PFS | Biological: CT-P39<br>* 150 mg/mL, Solution for injection in PFS<br>|
| Active Comparator: EU-approved Xolair (Part 2)<br>150 mg/mL, Solution for injection in PFS | Biological: EU-approved Xolair<br>* 150 mg/mL, Solution for injection in PFS<br>|
| Active Comparator: US-licensed Xolair (Part 2)<br>150 mg/mL, Solution for injection in PFS | Biological: US-licensed Xolair<br>* 150 mg/mL, Solution for injection in PFS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2 | 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) | up to day 127 | 
| Pharmacokinetic Outcome Measures [AUC0-last] for Part 2 | 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) | up to day 127 | 
| Pharmacokinetic Outcome Measures [Cmax] for Part 2 | 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) | up to day 127 | 

Secondary Outcome Measures

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