To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
NCT ID: NCT04018313
Last Updated: 2023-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
176 participants
INTERVENTIONAL
2020-05-28
2021-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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CT-P39 (Part 1)
150 mg/mL, Solution for injection in PFS
CT-P39
150 mg/mL, Solution for injection in PFS
EU-approved Xolair (Part 1)
150 mg/mL, Solution for injection in PFS
EU-approved Xolair
150 mg/mL, Solution for injection in PFS
CT-P39 (Part 2)
150 mg/mL, Solution for injection in PFS
CT-P39
150 mg/mL, Solution for injection in PFS
EU-approved Xolair (Part 2)
150 mg/mL, Solution for injection in PFS
EU-approved Xolair
150 mg/mL, Solution for injection in PFS
US-licensed Xolair (Part 2)
150 mg/mL, Solution for injection in PFS
US-licensed Xolair
150 mg/mL, Solution for injection in PFS
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Celltrion
INDUSTRY
Responsible Party
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Principal Investigators
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SungHyun Kim
Role: STUDY_DIRECTOR
Celltrion
Locations
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Phase 1 unit
Herston, Queensland, Australia
Phase 1 unit
Adelaide, South Australia, Australia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CT-P39 1.1
Identifier Type: -
Identifier Source: org_study_id
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