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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P39 (Part 1) | Experimental | 150 mg/mL, Solution for injection in PFS |
|
| EU-approved Xolair (Part 1) | Active Comparator | 150 mg/mL, Solution for injection in PFS |
|
| CT-P39 (Part 2) | Experimental | 150 mg/mL, Solution for injection in PFS |
|
| EU-approved Xolair (Part 2) | Active Comparator | 150 mg/mL, Solution for injection in PFS |
|
| US-licensed Xolair (Part 2) | Active Comparator | 150 mg/mL, Solution for injection in PFS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P39 | Biological | 150 mg/mL, Solution for injection in PFS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pharmacokinetic Outcome Measures [t1/2] for Part 1& Part 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SungHyun Kim | Celltrion | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase 1 unit | Herston | Queensland | 4006 | Australia | ||
| Phase 1 unit |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P39 (Part 1) | Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS). CT-P39: 150 mg/mL Solution for injection. |
| FG001 | EU-approved Xolair (Part 1) | Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS). EU-approved Xolair: 150 mg/mL Solution for injection. |
| FG002 | CT-P39 (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS). CT-P39: 150 mg/mL Solution for injection. |
| FG003 | EU-approved Xolair (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS). EU-approved Xolair: 150 mg/mL Solution for injection. |
| FG004 | US-licensed Xolair (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS). US-licensed Xolair: 150 mg/mL Solution for injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
ITT set: all subjects enrolled and randomly assigned to receive a dose of any study drug, regardless of whether or not any study drug was administered.
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P39 (Part 1) | Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS). CT-P39: 150 mg/mL Solution for injection. |
| BG001 | EU-approved Xolair (Part 1) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab. | Posted | Mean | Standard Deviation | day*μg/mL | up to day 127 |
|
All AEs were collected from the date the ICF was signed and AE reporting continued until the end of the subject's participation in this study (up to Day 127).
Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT-P39 (Part 1) | Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS). CT-P39: 150 mg/mL Solution for injection. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Head injury | Injury, poisoning and procedural complications | MedDRA Version 22.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA Version 22.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Keumyoung Ahn/Head of Clinical Planning 2 Department | Celltrion. Inc | +82 32 850 4190 | Keumyoung.ahn@celltrion.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 20, 2020 | Jun 16, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 1, 2021 | Jun 16, 2022 | SAP_001.pdf |
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| EU-approved Xolair |
| Biological |
150 mg/mL, Solution for injection in PFS |
|
| 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 |
|
To assess Terminal half-life (t1/2) of CT-P39, EU-approved Xolair, and US-licensed Xolair in healthy subjects
| up to day 127 |
| 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 |
| 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 |
| 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 |
| 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 |
| Adelaide |
| South Australia |
| 5000 |
| Australia |
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS).
EU-approved Xolair: 150 mg/mL Solution for injection.
| BG002 | CT-P39 (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS). CT-P39: 150 mg/mL Solution for injection. |
| BG003 | EU-approved Xolair (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS). EU-approved Xolair: 150 mg/mL Solution for injection. |
| BG004 | US-licensed Xolair (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS). US-licensed Xolair: 150 mg/mL Solution for injection. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index at screening | Mean | Standard Deviation | kg/m2 |
|
| EU-approved Xolair (Part 2) |
Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS). EU-approved Xolair: 150 mg/mL Solution for injection. |
| OG002 | US-licensed Xolair (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS). US-licensed Xolair: 150 mg/mL Solution for injection. |
|
|
|
| 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) | PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab. | Posted | Mean | Standard Deviation | day*μg/mL | 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) | PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab. | Posted | Mean | Standard Deviation | μg/mL | 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 | PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab. | Posted | Median | Full Range | day | 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 | PK set: all randomly assigned subjects who receive a complete dose of study drug and provide at least one post-treatment serum concentration above the lower limit of quantification for omalizumab. | Posted | Mean | Standard Deviation | day | 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 | PD set: all randomly assigned subjects who receive a complete dose of study drug and have at least one post-treatment free IgE or total IgE concentration above the lower limit of quantification. | Posted | Mean | Standard Deviation | IU/mL | 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 | PD set: all randomly assigned subjects who receive a complete dose of study drug and have at least one post-treatment free IgE or total IgE concentration above the lower limit of quantification. | Posted | Median | Full Range | day | 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 | PD set: all randomly assigned subjects who receive a complete dose of study drug and have at least one post-treatment free IgE or total IgE concentration above the lower limit of quantification. | Posted | Mean | Standard Deviation | IU/mL | 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 | PD set: all randomly assigned subjects who receive a complete dose of study drug and have at least one post-treatment free IgE or total IgE concentration above the lower limit of quantification. | Posted | Median | Full Range | day | up to day 127 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 4 |
| 15 |
| EG001 | EU-approved Xolair (Part 1) | Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS). EU-approved Xolair: 150 mg/mL Solution for injection. | 0 | 15 | 0 | 15 | 7 | 15 |
| EG002 | CT-P39 (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of CT-P39 via pre-filled syringe (PFS). CT-P39: 150 mg/mL Solution for injection. | 0 | 47 | 1 | 47 | 20 | 47 |
| EG003 | EU-approved Xolair (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of EU-approved Xolair via pre-filled syringe (PFS). EU-approved Xolair: 150 mg/mL Solution for injection. | 0 | 49 | 0 | 49 | 26 | 49 |
| EG004 | US-licensed Xolair (Part 2) | Healthy subjects were administered single subcutaneous (SC) injection of US-licensed Xolair via pre-filled syringe (PFS). US-licensed Xolair: 150 mg/mL, Solution for injection. | 0 | 50 | 0 | 50 | 31 | 50 |
| Catheter site pain | General disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Catheter site irritation | General disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 22.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA Version 22.1 | Systematic Assessment |
|
A confidentiality and non-disclosure agreement (CDA) was executed between Celltrion, Inc. and some PIs who have participated in publications funded by the sponsor for academic purposes for a period that is more than 180 days from the time submitted to the sponsor for review.
| The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates. | Ratio of geometric least square means | 99.30 | 2-Sided | 90 | 90.79 | 108.61 | Equivalence | The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax. |
| The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates. | Ratio of geometric least square means | 95.48 | 2-Sided | 90 | 87.36 | 104.37 | Equivalence | The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax. |
| The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates. | Ratio of geometric least square means | 103.88 | 2-Sided | 90 | 94.83 | 113.80 | Equivalence | The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax. |
| The statistical analysis of the log-transformed primary endpoints was based on an ANCOVA model with treatment as fixed effect and baseline body weight, total IgE level and sex as covariates. | Ratio of geometric least square means | 91.82 | 2-Sided | 90 | 83.87 | 100.52 | Equivalence | The similarity of PK between CT-P39 versus EU-approved Xolair, CT-P39 versus US-licensed Xolair, and EU-approved Xolair versus US-licensed Xolair was concluded if the 90% confidence intervals (CIs) of the ratios of geometric means of each comparison are entirely contained within 80% to 125% for AUC0-inf, AUC0-last, and Cmax. |