Trial Outcomes & Findings for To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects (NCT NCT03970824)
NCT ID: NCT03970824
Last Updated: 2021-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
312 participants
Primary outcome timeframe
up to Day 71
Results posted on
2021-11-18
Participant Flow
Participant milestones
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
103
|
103
|
106
|
|
Overall Study
COMPLETED
|
101
|
100
|
102
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
4
|
Reasons for withdrawal
| Measure |
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
|
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
|
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
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
1
|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
Baseline Characteristics
To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
Baseline characteristics by cohort
| Measure |
CT-P17
n=102 Participants
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
|
US-licensed Humira
n=102 Participants
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
|
EU-approved Humira
n=104 Participants
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
n=308 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.0 years
n=5 Participants
|
26.0 years
n=7 Participants
|
26.0 years
n=5 Participants
|
26.0 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
87 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
264 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
308 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
102 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
308 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
South Korea
|
102 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
308 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: up to Day 71Population: 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)
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.
Outcome measures
| Measure |
CT-P17
n=80 Participants
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
|
US-licensed Humira
n=86 Participants
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
|
EU-approved Humira
n=89 Participants
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
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf)
|
2656.5 h•μg/mL
Standard Deviation 1150.16
|
2469.7 h•μg/mL
Standard Deviation 917.47
|
2690.6 h•μg/mL
Standard Deviation 943.76
|
PRIMARY outcome
Timeframe: up to Day 71Population: 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)
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.
Outcome measures
| Measure |
CT-P17
n=96 Participants
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
|
US-licensed Humira
n=93 Participants
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
|
EU-approved Humira
n=98 Participants
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
|
|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last)
|
2372.7 h•μg/mL
Standard Deviation 954.82
|
2185.0 h•μg/mL
Standard Deviation 795.91
|
2394.7 h•μg/mL
Standard Deviation 866.95
|
PRIMARY outcome
Timeframe: up to Day 71Population: 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)
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.
Outcome measures
| Measure |
CT-P17
n=96 Participants
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
|
US-licensed Humira
n=93 Participants
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
|
EU-approved Humira
n=98 Participants
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
|
|---|---|---|---|
|
Maximum Serum Concentration (Cmax)
|
3.619 μg/mL
Standard Deviation 1.3522
|
3.556 μg/mL
Standard Deviation 1.1972
|
3.660 μg/mL
Standard Deviation 1.2212
|
SECONDARY outcome
Timeframe: up to Day 71Population: 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)
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.
Outcome measures
| Measure |
CT-P17
n=96 Participants
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
|
US-licensed Humira
n=93 Participants
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
|
EU-approved Humira
n=98 Participants
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
|
|---|---|---|---|
|
Time to the Maximum Serum Concentration (Tmax)
|
167.433 h
Interval 48.0 to 504.08
|
166.833 h
Interval 48.0 to 433.22
|
144.000 h
Interval 48.0 to 671.35
|
SECONDARY outcome
Timeframe: up to Day 71Population: 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)
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.
Outcome measures
| Measure |
CT-P17
n=80 Participants
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
|
US-licensed Humira
n=86 Participants
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
|
EU-approved Humira
n=89 Participants
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
|
|---|---|---|---|
|
Terminal Elimination Half-life (t1/2)
|
340.3 h
Standard Deviation 163.61
|
331.3 h
Standard Deviation 165.05
|
339.5 h
Standard Deviation 151.04
|
Adverse Events
CT-P17
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
US-licensed Humira
Serious events: 0 serious events
Other events: 27 other events
Deaths: 0 deaths
EU-approved Humira
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-P17
n=102 participants at risk
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
|
US-licensed Humira
n=102 participants at risk
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
|
EU-approved Humira
n=104 participants at risk
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
|
|---|---|---|---|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.98%
1/102 • 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.
|
0.00%
0/102 • 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.
|
0.00%
0/104 • 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.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.98%
1/102 • 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.
|
0.00%
0/102 • 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.
|
0.96%
1/104 • 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.
|
Other adverse events
| Measure |
CT-P17
n=102 participants at risk
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
|
US-licensed Humira
n=102 participants at risk
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
|
EU-approved Humira
n=104 participants at risk
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
|
|---|---|---|---|
|
General disorders
Injection site reaction
|
19.6%
20/102 • 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.
|
15.7%
16/102 • 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.
|
18.3%
19/104 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
3/102 • 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.
|
6.9%
7/102 • 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.
|
2.9%
3/104 • 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.
|
|
Nervous system disorders
Headache
|
5.9%
6/102 • 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.
|
5.9%
6/102 • 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.
|
6.7%
7/104 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place