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This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and EU-approved Humira) in Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P17 | Experimental | a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| US-licensed Humira | Active Comparator | a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| EU-approved Humira | Active Comparator | a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P17 | Biological | 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) | Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. | up to Day 71 |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) | Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. | up to Day 71 |
| Maximum Serum Concentration (Cmax) | Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. | up to Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the Maximum Serum Concentration (Tmax) | The secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. | up to Day 71 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sang Joon Lee | Celltrion, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | 13520 | South Korea | ||
| Seoul National University Bundang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33503313 | Derived | Yu KS, Jang IJ, Lim HS, Hong JH, Kim MG, Park MK, Cho DY, Park MS, Chung JY, Ghim JL, Lee S, Yoon SK, Kwon IS, Lee SJ, Kim SH, Bae YJ, Cha JB, Furst DE, Keystone E, Kay J. Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects. Clin Transl Sci. 2021 Jul;14(4):1280-1291. doi: 10.1111/cts.12967. Epub 2021 Mar 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P17 | a single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
| FG001 | US-licensed Humira | a single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
| FG002 | EU-approved Humira | a single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population (all randomly assigned subjects who received a complete or partial dose of study drug)
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P17 | a single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
| BG001 | US-licensed Humira |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) | Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. | Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab) | Posted | Mean | Standard Deviation | h•μg/mL | up to Day 71 |
|
Adverse events were assessed from the time the ICF was signed and until the end of the subject's participation in the study (up to Day 71).
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-P17 | a single subcutaneous (SC) injection via pre-filled syringe (PFS) CT-P17: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tympanic membrane perforation | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site reaction | General disorders | MedDRA 22.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SungHyun Kim | CELLTRION, Inc. | +82 32 850 5778 | SungHyun.Kim@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 | Jan 8, 2019 | Nov 2, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 27, 2019 | Nov 2, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000722909 | CT-P17 |
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| US-licensed Humira |
| Biological |
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
|
| EU-approved Humira | Biological | 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
|
| Terminal Elimination Half-life (t1/2) |
The secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. |
| up to Day 71 |
| Seongnam-si |
| Gyeonggi-do |
| 13620 |
| South Korea |
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | 54907 | South Korea |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | 28644 | South Korea |
| Inje University Busan Paik Hospital | Busan | 47392 | South Korea |
| Chungnam National University Hospital | Daejeon | 35015 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Adverse Event |
|
a single subcutaneous (SC) injection via pre-filled syringe (PFS)
US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
| BG002 | EU-approved Humira | a single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 |
| US-licensed Humira |
a single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
| OG002 | EU-approved Humira | a single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS |
|
|
|
| Primary | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) | Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. | Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab) | Posted | Mean | Standard Deviation | h•μg/mL | up to Day 71 |
|
|
|
|
| Primary | Maximum Serum Concentration (Cmax) | Primary endpoints were equivalence of PK between CT-P17 and reference drugs in terms of AUC0-inf, AUC0-last, and Cmax. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. | Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab) | Posted | Mean | Standard Deviation | μg/mL | up to Day 71 |
|
|
|
|
| Secondary | Time to the Maximum Serum Concentration (Tmax) | The secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. | Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab) | Posted | Median | Full Range | h | up to Day 71 |
|
|
|
| Secondary | Terminal Elimination Half-life (t1/2) | The secondary objective was to evaluate the additional PK parameters including Tmax and t1/2. Blood samples for PK analysis were obtained pre-dose and at 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504, 672, 1008, 1344, and 1680 hour post-dose. | Pharmacokinetic population (all randomly assigned subjects who received a complete dose of study drug and provided at least 1 post-treatment serum concentration above the lower limit of quantification for adalimumab) | Posted | Mean | Standard Deviation | h | up to Day 71 |
|
|
|
| 0 |
| 102 |
| 2 |
| 102 |
| 26 |
| 102 |
| EG001 | US-licensed Humira | a single subcutaneous (SC) injection via pre-filled syringe (PFS) US-licensed Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS | 0 | 102 | 0 | 102 | 27 | 102 |
| EG002 | EU-approved Humira | a single subcutaneous (SC) injection via pre-filled syringe (PFS) EU-approved Humira: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS | 0 | 104 | 1 | 104 | 27 | 104 |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
|
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| Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | Ratio of geometric least squares means | 93.93 | 2-Sided | 90 | 86.08 | 102.50 | Equivalence | PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%. |
| Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | Ratio of geometric least squares means | 100.79 | 2-Sided | 90 | 92.42 | 109.92 | Equivalence | PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%. |
| Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | Ratio of geometric least squares means | 98.20 | 2-Sided | 90 | 91.91 | 104.92 | Equivalence | PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%. |
| Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | Ratio of geometric least squares means | 100.05 | 2-Sided | 90 | 93.69 | 106.85 | Equivalence | PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means in AUC0-inf, AUC0-last, and Cmax were within the equivalence margin of 80-125%. |