Trial Outcomes & Findings for To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects (NCT NCT04525079)
NCT ID: NCT04525079
Last Updated: 2021-11-16
Results Overview
A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Up to Day 14 after the subject administered with the study drug (Day 1)
Results posted on
2021-11-16
Participant Flow
Participant milestones
| Measure |
CT-P59 10 mg/kg
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects
Baseline characteristics by cohort
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
n=8 Participants
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Age, Continuous
|
33.5 years
n=5 Participants
|
23.5 years
n=7 Participants
|
28.5 years
n=5 Participants
|
21.5 years
n=4 Participants
|
25 years
n=21 Participants
|
24 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
32 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
South Korea
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
32 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14 after the subject administered with the study drug (Day 1)Population: Safety set: All subjects who receive a full or partial dose of the study drugs
A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
n=8 Participants
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Preliminary Safety and Tolerability of CT-P59
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Preliminary Safety and Tolerability of CT-P59
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Preliminary Safety and Tolerability of CT-P59
Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 90 DaysPopulation: Safety set: All subjects who receive a full or partial dose of the study drugs.
A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
n=8 Participants
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Additional Safety of CT-P59 Including Immunogenicity
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
|
0 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Additional Safety of CT-P59 Including Immunogenicity
Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Additional Safety of CT-P59 Including Immunogenicity
Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Additional Safety of CT-P59 Including Immunogenicity
Number of Participants with Anti-Drug Antibody (ADA) positive to CT-P59
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 90 DaysPopulation: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data contain Area under the serum concentration-time curve (AUC) from time zero to infinity (AUC0-inf) and Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P59.
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last
Area under the concentration-time curve from time 0 to the last measured concentration (AUC0-last)
|
49593090.2 hr*ng/mL
Standard Deviation 15304853.54
|
86246911.1 hr*ng/mL
Standard Deviation 15738302.53
|
164581603.9 hr*ng/mL
Standard Deviation 21359705.90
|
321167775.4 hr*ng/mL
Standard Deviation 47167390.53
|
—
|
|
Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P59
|
52469185.0 hr*ng/mL
Standard Deviation 20377788.54
|
88353384.1 hr*ng/mL
Standard Deviation 17775504.91
|
167086786.9 hr*ng/mL
Standard Deviation 21899708.77
|
335692549.3 hr*ng/mL
Standard Deviation 58444099.42
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data contain Dose normalized AUC0-inf (AUC0-inf/Dose) and Dose normalized AUC0-last (AUC0-last/Dose)
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose
Dose normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (normalized to total body dose)
|
68774.1 hr*ng/mL/mg
Standard Deviation 22010.25
|
70620.6 hr*ng/mL/mg
Standard Deviation 20122.52
|
54763.5 hr*ng/mL/mg
Standard Deviation 6031.16
|
58981.8 hr*ng/mL/mg
Standard Deviation 7971.33
|
—
|
|
Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose
Dose normalized AUC0-last (AUC0-last/Dose) of CT-P59 (normalized to total body dose)
|
65200.8 hr*ng/mL/mg
Standard Deviation 15941.77
|
68847.6 hr*ng/mL/mg
Standard Deviation 18138.86
|
53932.1 hr*ng/mL/mg
Standard Deviation 5721.21
|
56474.7 hr*ng/mL/mg
Standard Deviation 6274.98
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data contains Maximum observed serum concentration(Cmax) of CT-P59
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Cmax
|
233166.7 ng/mL
Standard Deviation 37796.38
|
406333.3 ng/mL
Standard Deviation 43647.07
|
1020000.0 ng/mL
Standard Deviation 240084.15
|
1941666.7 ng/mL
Standard Deviation 267538.16
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Cmax/Dose
|
307.1 ng/mL/mg
Standard Deviation 27.11
|
321.5 ng/mL/mg
Standard Deviation 45.42
|
337.0 ng/mL/mg
Standard Deviation 91.60
|
342.0 ng/mL/mg
Standard Deviation 44.74
|
—
|
SECONDARY outcome
Timeframe: Up to 90 DaysPopulation: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data indicates Time to Cmax(Tmax) of CT-P59
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Tmax
|
2.080 hr
Interval 1.57 to 2.6
|
1.575 hr
Interval 1.48 to 5.48
|
2.070 hr
Interval 1.5 to 2.67
|
2.430 hr
Interval 1.53 to 13.63
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data contains Terminal half-life (t1/2) of CT-P59
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: t1/2
|
473.3 hr
Standard Deviation 181.26
|
426.4 hr
Standard Deviation 84.52
|
398.6 hr
Standard Deviation 36.30
|
526.8 hr
Standard Deviation 106.62
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: %AUCext
|
3.834 Percentage of AUC0-inf
Standard Deviation 5.2035
|
2.120 Percentage of AUC0-inf
Standard Deviation 1.6724
|
1.478 Percentage of AUC0-inf
Standard Deviation 0.59770
|
4.005 Percentage of AUC0-inf
Standard Deviation 2.3526
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data contains Terminal elimination rate constant (λz) of CT-P59
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: λz
|
0.001586 1/hr
Standard Deviation 0.00038316
|
0.001673 1/hr
Standard Deviation 0.00028913
|
0.001751 1/hr
Standard Deviation 0.00016119
|
0.001356 1/hr
Standard Deviation 0.00024242
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data contains Total body clearance (CL) of CT-P59
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: CL
|
15.46 mL/hr
Standard Deviation 3.5045
|
14.98 mL/hr
Standard Deviation 3.6165
|
18.46 mL/hr
Standard Deviation 2.1285
|
17.20 mL/hr
Standard Deviation 2.2033
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
Data contains Volume of distribution during the elimination phase (Vz) of CT-P59
Outcome measures
| Measure |
CT-P59 10 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 Participants
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameter: Vz
|
9848.9 mL
Standard Deviation 950.01
|
8880.3 mL
Standard Deviation 907.10
|
10532.2 mL
Standard Deviation 580.96
|
12805.5 mL
Standard Deviation 937.08
|
—
|
Adverse Events
CT-P59 10 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CT-P59 20 mg/kg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
CT-P59 40 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CT-P59 80 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CT-P59 10 mg/kg
n=6 participants at risk
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 participants at risk
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 participants at risk
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 participants at risk
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
n=8 participants at risk
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
16.7%
1/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/8 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
Other adverse events
| Measure |
CT-P59 10 mg/kg
n=6 participants at risk
Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 20 mg/kg
n=6 participants at risk
Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 40 mg/kg
n=6 participants at risk
Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
CT-P59 80 mg/kg
n=6 participants at risk
Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
Placebo
n=8 participants at risk
Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90.
|
|---|---|---|---|---|---|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
16.7%
1/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/8 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
12.5%
1/8 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
16.7%
1/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
16.7%
1/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/8 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
16.7%
1/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/8 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
16.7%
1/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/8 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
16.7%
1/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/8 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
16.7%
1/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/8 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
16.7%
1/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/6 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
0.00%
0/8 • Adverse events were assessed from the date the patient signed the ICF until end of study visit (up to Day 90).
From ICF signed date to end of study visit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place