Trial Outcomes & Findings for To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17 (NCT NCT04295356)
NCT ID: NCT04295356
Last Updated: 2021-01-19
Results Overview
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
180 participants
Primary outcome timeframe
Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdose
Results posted on
2021-01-19
Participant Flow
Participant milestones
| Measure |
Auto Injector
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
87
|
|
Overall Study
COMPLETED
|
92
|
83
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Auto Injector
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
To Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17
Baseline characteristics by cohort
| Measure |
Auto Injector
n=93 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=87 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.2 years
n=5 Participants
|
36.7 years
n=7 Participants
|
35.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
34 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
53 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Female fertility status
Surgically sterilized
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Female fertility status
Post-menopausal
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Female fertility status
Potentially able to bear children
|
32 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Female fertility status
Not applicable (male)
|
48 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Screening height
|
168.35 cm
STANDARD_DEVIATION 9.266 • n=5 Participants
|
169.57 cm
STANDARD_DEVIATION 9.795 • n=7 Participants
|
168.94 cm
STANDARD_DEVIATION 9.518 • n=5 Participants
|
|
Screening weight
|
71.61 kg
STANDARD_DEVIATION 12.888 • n=5 Participants
|
73.12 kg
STANDARD_DEVIATION 12.574 • n=7 Participants
|
72.34 kg
STANDARD_DEVIATION 12.725 • n=5 Participants
|
|
Screening BMI
|
25.12 kg/m2
STANDARD_DEVIATION 3.029 • n=5 Participants
|
25.32 kg/m2
STANDARD_DEVIATION 2.947 • n=7 Participants
|
25.22 kg/m2
STANDARD_DEVIATION 2.983 • n=5 Participants
|
|
Day -1 BMI
|
25.26 kg/m2
STANDARD_DEVIATION 2.967 • n=5 Participants
|
25.50 kg/m2
STANDARD_DEVIATION 2.939 • n=7 Participants
|
25.38 kg/m2
STANDARD_DEVIATION 2.948 • n=5 Participants
|
|
Day -1 weight category
Weight <80 kg
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Day -1 weight category
Weight ≥80 kg
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdosePopulation: Pharmacokinetics population
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=84 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=76 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Peak Plasma Concentration (Cmax)
|
4.141 μg/mL
Standard Deviation 1.5479
|
3.908 μg/mL
Standard Deviation 1.2620
|
PRIMARY outcome
Timeframe: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdosePopulation: Pharmacokinetics population; AUC0-inf PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=69 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=63 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC0-inf)
|
2819.5 h•μg/mL
Standard Deviation 945.82
|
2684.5 h•μg/mL
Standard Deviation 1031.16
|
PRIMARY outcome
Timeframe: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdosePopulation: Pharmacokinetics population
To demonstrate the PK similarity of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=84 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=76 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Zero to the Last Quantifiable Concentration (AUC0-last))
|
2451.3 h•μg/mL
Standard Deviation 1086.28
|
2292.9 h•μg/mL
Standard Deviation 1026.99
|
SECONDARY outcome
Timeframe: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdosePopulation: Pharmacokinetics population
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=84 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=76 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Time to Maximum Serum Concentration (Tmax)
|
132 hour
Interval 24.0 to 504.18
|
132 hour
Interval 48.0 to 505.97
|
SECONDARY outcome
Timeframe: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdosePopulation: Pharmacokinetics population; t1/2 PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=69 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=63 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Terminal Elimination Half-life (t1/2)
|
369.0 hour
Standard Deviation 139.76
|
355.4 hour
Standard Deviation 141.80
|
SECONDARY outcome
Timeframe: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdosePopulation: Pharmacokinetics population; λz PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=69 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=63 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Terminal Elimination Rate Constant (λz)
|
0.0022 1/h
Standard Deviation 0.00110
|
0.0023 1/h
Standard Deviation 0.00100
|
SECONDARY outcome
Timeframe: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdosePopulation: Pharmacokinetics population; CL/F PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=69 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=63 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Apparent Total Body Clearance (CL/F)
|
0.016 L/h
Standard Deviation 0.00740
|
0.017 L/h
Standard Deviation 0.00599
|
SECONDARY outcome
Timeframe: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdosePopulation: Pharmacokinetics population; Vz/F PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=69 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=63 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Apparent Volume of Distribution During the Terminal Phase After Non-IV Administration (Vz/F)
|
7.9 L
Standard Deviation 2.75
|
7.9 L
Standard Deviation 2.71
|
SECONDARY outcome
Timeframe: Day 1 predose, 6, 12, 24, 48, 72, 96, 108, 120, 132, 144, 168, 192, 336, 504 hours, Days 29, 43, 57, 71 postdosePopulation: Pharmacokinetics population; %AUCextrap PK parameter values were excluded from the statistical analysis after not meeting 1 or more of the following criteria; terminal elimination rate constant was calculated with an adjusted correlation coefficient r2 of ≥0.85 and/or a %AUCextrap (percentage of the area extrapolated for calculation of area under the concentration-time curve from time zero to infinity) ≤20%.
To evaluate the additional PK parameters of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=69 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=63 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Percentage of the Area Extrapolated for Calculation of AUC0-inf (%AUCextrap)
|
7.3 % of AUCextrap
Standard Deviation 4.52
|
7.1 % of AUCextrap
Standard Deviation 4.52
|
SECONDARY outcome
Timeframe: Day 1 predose, Days 15, 29, 57, 71 postdosePopulation: Safety population
To evaluate immunogenicity of CT-P17 SC administration via AI versus PFS in healthy subjects
Outcome measures
| Measure |
Auto Injector
n=93 Participants
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=87 Participants
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Summary of Immunogenicity Assay
Baseline (Day 1 predose) ADA · Positive
|
10 Participants
|
5 Participants
|
|
Summary of Immunogenicity Assay
Baseline (Day 1 predose) ADA · Negative
|
83 Participants
|
82 Participants
|
|
Summary of Immunogenicity Assay
Baseline (Day 1 predose) ADA · Missing or not applicable
|
0 Participants
|
0 Participants
|
|
Summary of Immunogenicity Assay
Day 15 ADA · Positive
|
62 Participants
|
59 Participants
|
|
Summary of Immunogenicity Assay
Day 15 ADA · Negative
|
30 Participants
|
27 Participants
|
|
Summary of Immunogenicity Assay
Day 15 ADA · Missing or not applicable
|
1 Participants
|
1 Participants
|
|
Summary of Immunogenicity Assay
Day 29 ADA · Positive
|
78 Participants
|
73 Participants
|
|
Summary of Immunogenicity Assay
Day 29 ADA · Negative
|
10 Participants
|
11 Participants
|
|
Summary of Immunogenicity Assay
Day 29 ADA · Missing or not applicable
|
5 Participants
|
3 Participants
|
|
Summary of Immunogenicity Assay
Day 57 ADA · Positive
|
82 Participants
|
73 Participants
|
|
Summary of Immunogenicity Assay
Day 57 ADA · Negative
|
6 Participants
|
7 Participants
|
|
Summary of Immunogenicity Assay
Day 57 ADA · Missing or not applicable
|
5 Participants
|
7 Participants
|
|
Summary of Immunogenicity Assay
End-of-study ADA · Positive
|
87 Participants
|
78 Participants
|
|
Summary of Immunogenicity Assay
End-of-study ADA · Negative
|
4 Participants
|
6 Participants
|
|
Summary of Immunogenicity Assay
End-of-study ADA · Missing or not applicable
|
2 Participants
|
3 Participants
|
|
Summary of Immunogenicity Assay
Baseline (Day 1 predose) NAb · Positive
|
0 Participants
|
0 Participants
|
|
Summary of Immunogenicity Assay
Baseline (Day 1 predose) NAb · Negative
|
10 Participants
|
5 Participants
|
|
Summary of Immunogenicity Assay
Baseline (Day 1 predose) NAb · Missing or not applicable
|
83 Participants
|
82 Participants
|
|
Summary of Immunogenicity Assay
Day 15 NAb · Positive
|
21 Participants
|
25 Participants
|
|
Summary of Immunogenicity Assay
Day 15 NAb · Negative
|
41 Participants
|
34 Participants
|
|
Summary of Immunogenicity Assay
Day 15 NAb · Missing or not applicable
|
31 Participants
|
28 Participants
|
|
Summary of Immunogenicity Assay
Day 29 NAb · Positive
|
39 Participants
|
44 Participants
|
|
Summary of Immunogenicity Assay
Day 29 NAb · Negative
|
39 Participants
|
29 Participants
|
|
Summary of Immunogenicity Assay
Day 29 NAb · Missing or not applicable
|
15 Participants
|
14 Participants
|
|
Summary of Immunogenicity Assay
Day 57 NAb · Positive
|
65 Participants
|
60 Participants
|
|
Summary of Immunogenicity Assay
Day 57 NAb · Negative
|
17 Participants
|
13 Participants
|
|
Summary of Immunogenicity Assay
Day 57 NAb · Missing or not applicable
|
11 Participants
|
14 Participants
|
|
Summary of Immunogenicity Assay
End-of-study NAb · Positive
|
73 Participants
|
68 Participants
|
|
Summary of Immunogenicity Assay
End-of-study NAb · Negative
|
14 Participants
|
10 Participants
|
|
Summary of Immunogenicity Assay
End-of-study NAb · Missing or not applicable
|
6 Participants
|
9 Participants
|
Adverse Events
Auto Injector
Serious events: 2 serious events
Other events: 55 other events
Deaths: 0 deaths
Pre-filled Syringe
Serious events: 0 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Auto Injector
n=93 participants at risk
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=87 participants at risk
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Infections and infestations
Viral meningitis
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
Other adverse events
| Measure |
Auto Injector
n=93 participants at risk
a single dose (40 mg) of CT-P17 via AI
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
Pre-filled Syringe
n=87 participants at risk
a single dose (40 mg) of CT-P17 via PFS
CT-P17: all subjects will receive a single dose (40 mg) of CT-P17 via either AI or PFS on Day 1 followed by 10 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Cardiac disorders
Palpitations
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Eye disorders
Vision blurred
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.2%
2/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.3%
4/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/93 • 10 weeks
|
3.4%
3/87 • 10 weeks
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
General disorders
Chills
|
1.1%
1/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
General disorders
Fatigue
|
1.1%
1/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
General disorders
Feeling hot
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
General disorders
Injection site reaction
|
8.6%
8/93 • 10 weeks
|
6.9%
6/87 • 10 weeks
|
|
General disorders
Oedema peripheral
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Immune system disorders
Hypersensitivity
|
3.2%
3/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Infections and infestations
Cystitis
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Infections and infestations
Pyuria
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
3.2%
3/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Infections and infestations
Urinary tract infection
|
3.2%
3/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Infections and infestations
Vaginal infection
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.2%
2/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
2.2%
2/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Injury, poisoning and procedural complications
Skin laceration
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Investigations
Alanine aminotransferase increased
|
3.2%
3/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/93 • 10 weeks
|
3.4%
3/87 • 10 weeks
|
|
Investigations
Blood creatine phosphokinase MB increased
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
7.5%
7/93 • 10 weeks
|
4.6%
4/87 • 10 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Investigations
C-reactive protein increased
|
5.4%
5/93 • 10 weeks
|
5.7%
5/87 • 10 weeks
|
|
Investigations
Electrocardiogram T-wave abnormal
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Investigations
Haematocrit decreased
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Investigations
Haemoglobin decreased
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Investigations
Hepatic enzyme increased
|
1.1%
1/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Investigations
Urine output decreased
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Investigations
White blood cell count increased
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
8.6%
8/93 • 10 weeks
|
5.7%
5/87 • 10 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
4/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.3%
4/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.5%
7/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
2/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Nervous system disorders
Aura
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Nervous system disorders
Headache
|
11.8%
11/93 • 10 weeks
|
9.2%
8/87 • 10 weeks
|
|
Nervous system disorders
Paraesthesia
|
1.1%
1/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Renal and urinary disorders
Haematuria
|
2.2%
2/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/93 • 10 weeks
|
3.4%
3/87 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
2/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
2/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
1.1%
1/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
1/93 • 10 weeks
|
2.3%
2/87 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Macule
|
1.1%
1/93 • 10 weeks
|
0.00%
0/87 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/93 • 10 weeks
|
1.1%
1/87 • 10 weeks
|
Additional Information
Sung Hyun Kim, Head of Clinical Planning Department
CELLTRION, Inc.
Phone: +82 32 850 5778
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place