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

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ClinicalTrials.gov Identifier: NCT04018313
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Celltrion

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Biological: CT-P39 Biological: EU-approved Xolair Biological: US-licensed Xolair Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 177 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : May 28, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

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




Primary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [Safety] [ Time Frame: up to day 127 ]
    Treatment-Emergent Adverse Events (TEAEs) of CT-P39, compared to that of EU-approved Xolair in healthy subjects

  2. Pharmacokinetic Outcome Measures [AUC0-inf] [ 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)

  3. Pharmacokinetic Outcome Measures [AUC0-last] [ 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)

  4. Pharmacokinetic Outcome Measures [Cmax] [ 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 Outcome Measures :
  1. Pharmacokinetic Outcome Measures [Tmax] [ 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] [ 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. Pharmacokinetic Outcome Measures [%AUCext] [ Time Frame: up to day 127 ]
    To assess Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects

  4. Pharmacokinetic Outcome Measures [λz] [ Time Frame: up to day 127 ]
    To assess Terminal elimination rate constant (λz) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects

  5. Pharmacokinetic Outcome Measures [Apparent total body clearance (CL/F)] [ Time Frame: up to day 127 ]
    To assess Apparent total body clearance (CL/F) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects

  6. Pharmacokinetic Outcome Measures [Mean residence time (MRT)] [ Time Frame: up to day 127 ]
    To assess Mean residence time (MRT) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects

  7. Pharmacodynamics [IgE level] [ Time Frame: up to day 127 ]
    Free IgE and total IgE levels (the sum of free and omalizumab-bound IgE) in the serum samples from subjects

  8. Incidence of Adverse events of Special Interest [Safety] [ Time Frame: up to day 127 ]
    Adverse events of Special Interest (AESI) of CT-P39, EU approved Xolair, and US-licensed Xolair in healthy subjects (e.g., Allergic reactions type 1/anaphylaxis, injection site reactions, serum sickness/serum sickness-like reactions, and parasitic infections)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 29.9 kg/m2(both inclusive).
  • Subject with an 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018313


Contacts
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Contact: MinJi Ma +82328505720 minji.ma@celltrion.com

Locations
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Australia, Queensland
Phase 1 unit Recruiting
Herston, Queensland, Australia, 4006
Australia, South Australia
Phase 1 unit Recruiting
Adelaide, South Australia, Australia, 5000
Sponsors and Collaborators
Celltrion
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Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT04018313    
Other Study ID Numbers: CT-P39 1.1
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Omalizumab
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs