To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
Sponsor
Celltrion (Industry)
Overall Status
Completed
CT.gov ID
NCT03970824
Collaborator
(none)
312
9
3
7.5
34.7
4.6
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
312 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 CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects
Actual Study Start Date
:
May 31, 2019
Actual Primary Completion Date
:
Nov 13, 2019
Actual Study Completion Date
:
Jan 15, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: CT-P17 a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
Biological: CT-P17
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
|
| Active Comparator: US-licensed Humira a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
Biological: US-licensed Humira
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
|
| Active Comparator: EU-approved Humira a single subcutaneous (SC) injection via pre-filled syringe (PFS) |
Biological: EU-approved Humira
40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
|
Outcome Measures
Primary Outcome Measures
- Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) [up to Day 71]
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.
- Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) [up to Day 71]
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.
- Maximum Serum Concentration (Cmax) [up to Day 71]
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.
Secondary Outcome Measures
- Time to the Maximum Serum Concentration (Tmax) [up to Day 71]
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.
- Terminal Elimination Half-life (t1/2) [up to Day 71]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
19 Years
to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Healthy subjects
-
BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth
Exclusion Criteria:
-
A medical history and/or condition that is considered significant
-
Clinically significant allergic reactions, hypersensitivity
-
History or current infection of hepatitis B virus (except for past resolved infection), hepatitis C virus, human immunodeficiency virus, or syphilis
-
Active or latent Tuberculosis
-
History of malignancy
-
Previous monoclonal antibody or fusion protein treatment, or current use of any biologic
-
Planning to be pregnant or father a child or donate sperm within 5 month after administration
-
Undergone treatment with an investigational drug or participated in another clinical trial within 90 days or 5 half-lives (whichever is longer)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chungbuk National University Hospital | Cheongju-si | Chungcheongbuk-do | Korea, Republic of | 28644 |
| 2 | CHA Bundang Medical Center | Seongnam-si | Gyeonggi-do | Korea, Republic of | 13520 |
| 3 | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | Korea, Republic of | 13620 |
| 4 | Chonbuk National University Hospital | Jeonju | Jeollabuk-do | Korea, Republic of | 54907 |
| 5 | Inje University Busan Paik Hospital | Busan | Korea, Republic of | 47392 | |
| 6 | Chungnam National University Hospital | Daejeon | Korea, Republic of | 35015 | |
| 7 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 8 | Severance Hospital | Seoul | Korea, Republic of | 03722 | |
| 9 | Asan Medical Center | Seoul | Korea, Republic of | 05505 |
Sponsors and Collaborators
- Celltrion
Investigators
- Study Director: Sang Joon Lee, Celltrion, Inc.
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Celltrion
ClinicalTrials.gov Identifier:
NCT03970824
Other Study ID Numbers:
- CT-P17 1.1
First Posted:
Jun 3, 2019
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | CT-P17 | US-licensed Humira | EU-approved Humira |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Period Title: Overall Study | |||
| STARTED | 103 | 103 | 106 |
| COMPLETED | 101 | 100 | 102 |
| NOT COMPLETED | 2 | 3 | 4 |
Baseline Characteristics
| Arm/Group Title | CT-P17 | US-licensed Humira | EU-approved Humira | Total |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 | Total of all reporting groups |
| Overall Participants | 102 | 102 | 104 | 308 |
| Age (years) [Median (Full Range) ] | ||||
| Median (Full Range) [years] |
25.0
|
26.0
|
26.0
|
26.0
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
15
14.7%
|
14
13.7%
|
15
14.4%
|
44
14.3%
|
| Male |
87
85.3%
|
88
86.3%
|
89
85.6%
|
264
85.7%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
102
100%
|
102
100%
|
104
100%
|
308
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
102
100%
|
102
100%
|
104
100%
|
308
100%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||
| South Korea |
102
100%
|
102
100%
|
104
100%
|
308
100%
|
Outcome Measures
| Title | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) |
|---|---|
| Description | 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. |
| Time Frame | up to Day 71 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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) |
| Arm/Group Title | CT-P17 | US-licensed Humira | EU-approved Humira |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 80 | 86 | 89 |
| Mean (Standard Deviation) [h•μg/mL] |
2656.5
(1150.16)
|
2469.7
(917.47)
|
2690.6
(943.76)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CT-P17, US-licensed Humira |
|---|---|---|
| Comments | Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | |
| Type of Statistical Test | Equivalence | |
| Comments | 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 Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 105.79 | |
| Confidence Interval |
(2-Sided) 90% 97.19 to 115.16 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US-licensed Humira, EU-approved Humira |
|---|---|---|
| Comments | Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | |
| Type of Statistical Test | Equivalence | |
| Comments | 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 Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 92.63 | |
| Confidence Interval |
(2-Sided) 90% 85.29 to 100.61 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | CT-P17, EU-approved Humira |
|---|---|---|
| Comments | Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | |
| Type of Statistical Test | Equivalence | |
| Comments | 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 Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 98.00 | |
| Confidence Interval |
(2-Sided) 90% 90.06 to 106.63 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) |
|---|---|
| Description | 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. |
| Time Frame | up to Day 71 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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) |
| Arm/Group Title | CT-P17 | US-licensed Humira | EU-approved Humira |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 96 | 93 | 98 |
| Mean (Standard Deviation) [h•μg/mL] |
2372.7
(954.82)
|
2185.0
(795.91)
|
2394.7
(866.95)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CT-P17, US-licensed Humira |
|---|---|---|
| Comments | Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | |
| Type of Statistical Test | Equivalence | |
| Comments | 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 Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 107.30 | |
| Confidence Interval |
(2-Sided) 90% 98.29 to 117.13 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US-licensed Humira, EU-approved Humira |
|---|---|---|
| Comments | Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | |
| Type of Statistical Test | Equivalence | |
| Comments | 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 Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 93.93 | |
| Confidence Interval |
(2-Sided) 90% 86.08 to 102.50 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | CT-P17, EU-approved Humira |
|---|---|---|
| Comments | Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | |
| Type of Statistical Test | Equivalence | |
| Comments | 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 Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 100.79 | |
| Confidence Interval |
(2-Sided) 90% 92.42 to 109.92 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Maximum Serum Concentration (Cmax) |
|---|---|
| Description | 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. |
| Time Frame | up to Day 71 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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) |
| Arm/Group Title | CT-P17 | US-licensed Humira | EU-approved Humira |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 96 | 93 | 98 |
| Mean (Standard Deviation) [μg/mL] |
3.619
(1.3522)
|
3.556
(1.1972)
|
3.660
(1.2212)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | CT-P17, US-licensed Humira |
|---|---|---|
| Comments | Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | |
| Type of Statistical Test | Equivalence | |
| Comments | 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 Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 101.89 | |
| Confidence Interval |
(2-Sided) 90% 95.33 to 108.89 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | US-licensed Humira, EU-approved Humira |
|---|---|---|
| Comments | Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | |
| Type of Statistical Test | Equivalence | |
| Comments | 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 Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 98.20 | |
| Confidence Interval |
(2-Sided) 90% 91.91 to 104.92 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | CT-P17, EU-approved Humira |
|---|---|---|
| Comments | Statistical analysis of primary PK parameters was performed using an analysis of covariance model (ANCOVA) including covariates for gender, study center, and body weight. | |
| Type of Statistical Test | Equivalence | |
| Comments | 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 Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | Ratio of geometric least squares means |
| Estimated Value | 100.05 | |
| Confidence Interval |
(2-Sided) 90% 93.69 to 106.85 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Time to the Maximum Serum Concentration (Tmax) |
|---|---|
| Description | 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. |
| Time Frame | up to Day 71 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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) |
| Arm/Group Title | CT-P17 | US-licensed Humira | EU-approved Humira |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 96 | 93 | 98 |
| Median (Full Range) [h] |
167.433
|
166.833
|
144.000
|
| Title | Terminal Elimination Half-life (t1/2) |
|---|---|
| Description | 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. |
| Time Frame | up to Day 71 |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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) |
| Arm/Group Title | CT-P17 | US-licensed Humira | EU-approved Humira |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | 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 |
| Measure Participants | 80 | 86 | 89 |
| Mean (Standard Deviation) [h] |
340.3
(163.61)
|
331.3
(165.05)
|
339.5
(151.04)
|
Adverse Events
| Time Frame | 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). | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Only treatment-emergent adverse events and treatment-emergent serious adverse events were summarized. | |||||
| Arm/Group Title | CT-P17 | US-licensed Humira | EU-approved Humira | |||
| Arm/Group Description | 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 | 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 | 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 | |||
All Cause Mortality |
||||||
| CT-P17 | US-licensed Humira | EU-approved Humira | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/102 (0%) | 0/102 (0%) | 0/104 (0%) | |||
Serious Adverse Events |
||||||
| CT-P17 | US-licensed Humira | EU-approved Humira | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/102 (2%) | 0/102 (0%) | 1/104 (1%) | |||
| Ear and labyrinth disorders | ||||||
| Tympanic membrane perforation | 1/102 (1%) | 0/102 (0%) | 0/104 (0%) | |||
| Injury, poisoning and procedural complications | ||||||
| Road traffic accident | 1/102 (1%) | 0/102 (0%) | 1/104 (1%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| CT-P17 | US-licensed Humira | EU-approved Humira | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 26/102 (25.5%) | 27/102 (26.5%) | 27/104 (26%) | |||
| General disorders | ||||||
| Injection site reaction | 20/102 (19.6%) | 16/102 (15.7%) | 19/104 (18.3%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 3/102 (2.9%) | 7/102 (6.9%) | 3/104 (2.9%) | |||
| Nervous system disorders | ||||||
| Headache | 6/102 (5.9%) | 6/102 (5.9%) | 7/104 (6.7%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | SungHyun Kim |
|---|---|
| Organization | CELLTRION, Inc. |
| Phone | +82 32 850 5778 |
| SungHyun.Kim@celltrion.com |
Responsible Party:
Celltrion
ClinicalTrials.gov Identifier:
NCT03970824
Other Study ID Numbers:
- CT-P17 1.1
First Posted:
Jun 3, 2019
Last Update Posted:
Nov 18, 2021
Last Verified:
Nov 1, 2021