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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: CT-P39; Biological: EU-approved Xolair; Biological: US-licensed Xolair

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Phase 1 unit
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Phase 1 unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Celltrion
• Investigators: Study Director: SungHyun Kim, Celltrion

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2020
• Primary Completion (Actual): March 27, 2021
• Study Completion (Actual): April 30, 2021

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 10, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Antibodies, Monoclonal; Omalizumab
• Other Study ID Numbers: CT-P39 1.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No