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Completed

NCT Number: NCT04018313

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Phase 1 unit, Herston, Queensland, Australia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT-P39

Biological

150 mg/mL, Solution for injection in PFS

EU-Approved XOLAIR

Biological

150 mg/mL, Solution for injection in PFS

US-licensed XOLAIR

Biological

150 mg/mL, Solution for injection in PFS

Primary outcomes

  1. 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)

  2. 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)

  3. 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2019
Registry last updated
May 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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