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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 27, 2021

Interventions

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

Arms, Groups and Cohorts

  • Experimental: CT-P39 (Part 1)
    • 150 mg/mL, Solution for injection in PFS
  • Active Comparator: EU-approved Xolair (Part 1)
    • 150 mg/mL, Solution for injection in PFS
  • Experimental: CT-P39 (Part 2)
    • 150 mg/mL, Solution for injection in PFS
  • Active Comparator: EU-approved Xolair (Part 2)
    • 150 mg/mL, Solution for injection in PFS
  • Active Comparator: US-licensed Xolair (Part 2)
    • 150 mg/mL, Solution for injection in PFS

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetic Outcome Measures [AUC0-inf] for Part 2
    • Time Frame: 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 [AUC0-last] for Part 2
    • Time Frame: 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)
  • Pharmacokinetic Outcome Measures [Cmax] for Part 2
    • Time Frame: 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)

Secondary Measures

  • Pharmacokinetic Outcome Measures [Tmax] for Part 1& Part 2
    • Time Frame: up to day 127
    • To assess Time to Cmax (Tmax) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
  • Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2
    • Time Frame: up to day 127
    • To assess Terminal half-life (t1/2) 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
    • Time Frame: 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 [Tmin of Free IgE] for Part 1 & Part 2
    • Time Frame: 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
  • Pharmacodynamic Outcome Measures [Cmax of Total IgE] for Part 1 & Part 2
    • Time Frame: 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
  • Pharmacodynamic Outcome Measures [Tmax of Total IgE] for Part 1 & Part 2
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Celltrion
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • SungHyun Kim, Study Director, Celltrion

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