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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018313
• Other study ID #: CT-P39 1.1
• Status: Completed
• Phase: Phase 1
• Start date: May 28, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2021
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: April 30, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• CT-P39
150 mg/mL, Solution for injection in PFS
• EU-approved Xolair
150 mg/mL, Solution for injection in PFS
• CT-P39
150 mg/mL, Solution for injection in PFS
• EU-approved Xolair
150 mg/mL, Solution for injection in PFS
• US-licensed Xolair
150 mg/mL, Solution for injection in PFS

Locations

Country	Name	City	State
Australia	Phase 1 unit	Adelaide	South Australia
Australia	Phase 1 unit	Herston	Queensland

Sponsors (1)

Lead Sponsor	Collaborator
Celltrion

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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