Trial Outcomes & Findings for This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19) (NCT NCT04593641)
NCT ID: NCT04593641
Last Updated: 2022-04-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Up to Day 14
Results posted on
2022-04-08
Participant Flow
Participant milestones
| Measure |
CT-P59 20 mg/kg
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
3
|
|
Overall Study
COMPLETED
|
4
|
5
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19)
Baseline characteristics by cohort
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
Total
n=18 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 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
|
|
Age, Continuous
|
59 years
n=5 Participants
|
51 years
n=7 Participants
|
52 years
n=5 Participants
|
50 years
n=4 Participants
|
52 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=21 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
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
18 Participants
n=21 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 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
|
|
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
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 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
|
|
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
|
|
Region of Enrollment
South Korea
|
5 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
6 participants
n=21 Participants
|
|
Region of Enrollment
Romania
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
12 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Safety set
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Patients With TEAEs
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Safety set
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Safety set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to Day 14Population: Safety set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 28Population: Intent-to-Treat (ITT) set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
The number of patients with negative for qPCR
|
4 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
|
The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
The number of patients with positive for qPCR
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
The number of patients who did not obtain any result for qPCR
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Intent-to-Treat (ITT) set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
|
17.49 days
Standard Deviation 6.891
|
12.50 days
Standard Deviation 10.194
|
18.51 days
Standard Deviation 9.344
|
14.19 days
Standard Deviation 11.879
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Intent-to-Treat (ITT) set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve of Viral Titers for qPCR
|
55.45 (log10cp/mL)*days
Standard Deviation 15.964
|
41.05 (log10cp/mL)*days
Standard Deviation 38.738
|
56.26 (log10cp/mL)*days
Standard Deviation 28.358
|
60.26 (log10cp/mL)*days
Standard Deviation 60.062
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Intent-to-Treat (ITT) set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Actual results for viral shedding in nasopharyngeal swab specimens for qPCR at Day 28
|
0.382 log10cp/mL
Standard Deviation 0.8542
|
0.452 log10cp/mL
Standard Deviation 1.0107
|
1.008 log10cp/mL
Standard Deviation 1.1665
|
0.637 log10cp/mL
Standard Deviation 1.1027
|
|
Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Change from baseline for viral shedding in nasopharyngeal swab specimens for qPCR up to Day 28
|
-6.326 log10cp/mL
Standard Deviation 0.9801
|
-4.258 log10cp/mL
Standard Deviation 1.8477
|
-5.723 log10cp/mL
Standard Deviation 1.6683
|
-4.367 log10cp/mL
Standard Deviation 1.0060
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Intent-to-Treat (ITT) set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Patients With Clinical Recovery
|
5 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Patients Requiring Supplemental Oxygen
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Intent-to-Treat (ITT) set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Patients With Intensive Care Unit Transfer
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Intent-to-Treat (ITT) set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Mechanical Ventilation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Intent-to-Treat (ITT) set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Patients With All-cause Mortality
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: Intent-to-Treat (ITT) set.
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 Participants
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Number of Patients With Hospital Admission
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set.
The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59
|
84538893.8 hr*ng/mL
Standard Deviation 10202293.97
|
178065255.1 hr*ng/mL
Standard Deviation 16390524.47
|
433826801.0 hr*ng/mL
Standard Deviation 112102013.80
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set.
The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Time to Cmax (Tmax) of CT-P59
|
2.500 hr
Interval 1.5 to 2.5
|
2.500 hr
Interval 1.55 to 2.58
|
2.500 hr
Interval 1.53 to 2.53
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set.
The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose)
|
62595.7 hr*ng/mL/mg
Standard Deviation 7539.48
|
58838.6 hr*ng/mL/mg
Standard Deviation 10090.23
|
60936.0 hr*ng/mL/mg
Standard Deviation 11969.30
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Terminal Half-life (t1/2) of CT-P59
|
357.1 hr
Standard Deviation 41.06
|
380.8 hr
Standard Deviation 25.35
|
496.3 hr
Standard Deviation 133.26
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59
|
5.917 Percentage of the extrapolated area
Standard Deviation 10.073
|
1.242 Percentage of the extrapolated area
Standard Deviation 0.48091
|
3.953 Percentage of the extrapolated area
Standard Deviation 2.2905
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90Population: Pharmacokinetic (PK) set.
The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Terminal Elimination Rate Constant (λz) of CT-P59
|
0.00196 1/hr
Standard Deviation 0.00024353
|
0.001827 1/hr
Standard Deviation 0.00012290
|
0.001493 1/hr
Standard Deviation 0.00046237
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Total Body Clearance (CL) of CT-P59
|
16.18 mL/hr
Standard Deviation 2.0775
|
17.46 mL/hr
Standard Deviation 3.4120
|
16.86 mL/hr
Standard Deviation 2.8482
|
—
|
SECONDARY outcome
Timeframe: Up to Day 90The PK parameters were calculated by noncompartmental methods based on the actual sampling time points using Phoenix WinNonlin Version 8.3 (Pharsight, St Louis, Missouri, USA).
Outcome measures
| Measure |
CT-P59 20 mg/kg
n=5 Participants
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 Participants
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 Participants
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Volume of Distribution During the Elimination Phase (Vz) of CT-P59
|
8351.9 mL
Standard Deviation 1676.84
|
9514.7 mL
Standard Deviation 1357.53
|
11968.2 mL
Standard Deviation 3725.56
|
—
|
Adverse Events
CT-P59 20 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CT-P59 40 mg/kg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CT-P59 80 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CT-P59 20 mg/kg
n=5 participants at risk
Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 40 mg/kg
n=5 participants at risk
Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.
|
CT-P59 80 mg/kg
n=5 participants at risk
Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
|
Placebo
n=3 participants at risk
Patients were administered Placebo (same volume as the active dose used for CT-P59 in each cohort) by IV infusion with standard of care on Day 1.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Eye disorders
Conjunctival haemorrhage
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
2/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
33.3%
1/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Infections and infestations
Candida infection
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Psychiatric disorders
Insomnia
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
20.0%
1/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
|
Vascular disorders
Hypertension
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
0.00%
0/5 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
33.3%
1/3 • Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Treatment Period: Day 1 to Day 90
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place