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)

• Sponsor: Celltrion (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04593641
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 3
• Actual Duration (Months): 7
• Patients Per Site Per Month: 2.6

Study Details

Study Description

Brief Summary

This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Virology of CT-P59 in Patient with Mild Symptoms of Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Infection.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Infection	Biological: CT-P59	Phase 1

Detailed Description

'CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike receptor binding protein as a treatment for SARS CoV 2 infection. CT-P59 is currently being developed by the Sponsor as a potential treatment for SARS-CoV-2 infection. In this study, safety, tolerability and virology of CT-P59 will be evaluated in patient with mild symptoms of SARS-CoV-2 Infection.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Pilot Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient With Mild Symptoms of SARS-CoV-2 Infection
• Actual Study Start Date: Sep 4, 2020
• Actual Primary Completion Date: Oct 26, 2020
• Actual Study Completion Date: Apr 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 will receive a dose of CT-P59 or matching placebo Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59	Biological: CT-P59; administered
Experimental: Cohort 2 will receive a dose of CT-P59 or matching placebo Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59	Biological: CT-P59; administered
Experimental: Cohort 3 will receive a dose of CT-P59 or matching placebo Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59	Biological: CT-P59; administered

Outcome Measures

Primary Outcome Measures

1. Number of Patients With TEAEs [Up to Day 14]

2. Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs) [Up to Day 14]

3. Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction) [Up to Day 14]

4. Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE) [Up to Day 14]

Secondary Outcome Measures

1. The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) [At Day 28]

2. Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR [Up to Day 28]

3. Area Under the Concentration-time Curve of Viral Titers for qPCR [Up to Day 28]

4. Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR [Up to Day 28]

5. Number of Patients With Clinical Recovery [Up to Day 28]

6. Number of Patients Requiring Supplemental Oxygen [Up to Day 28]

7. Number of Patients With Intensive Care Unit Transfer [Up to Day 28]

8. Number of Mechanical Ventilation [Up to Day 28]

9. Number of Patients With All-cause Mortality [Up to Day 28]

10. Number of Patients With Hospital Admission [Up to Day 28]

11. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59 [Up to Day 90]

    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).

12. Time to Cmax (Tmax) of CT-P59 [Up to Day 90]

    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).

13. Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose) [Up to Day 90]

    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).

14. Terminal Half-life (t1/2) of CT-P59 [Up to Day 90]

    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).

15. Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59 [Up to Day 90]

    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).

16. Terminal Elimination Rate Constant (λz) of CT-P59 [Up to Day 90]

    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).

17. Total Body Clearance (CL) of CT-P59 [Up to Day 90]

    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).

18. Volume of Distribution During the Elimination Phase (Vz) of CT-P59 [Up to Day 90]

    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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Each patient must meet all of the following criteria to be randomized in this study:

1. Adult male or female patient, aged between 18 to 60 years (both inclusive).

2. Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.

3. Patient has mild conditions meeting all of the following criteria:

4. Oxygen saturation ≥ 94% on room air.

5. Not requiring supplemental oxygen.

6. Onset of symptom is no more than 7 days prior to the study drug administration.

Exclusion Criteria:

1. Patient with severe condition meeting one of the following:

2. Respiratory distress with respiratory rate ≥ 30 breaths/min.

3. Requires supplemental oxygen.

4. Experience shock.

5. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.

6. Any other conditions suspected of being severe symptoms of SARS-CoV-2 infection, in the opinion of the investigator, including but not limited to radiographic findings in lung.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Incheon Medical Center	Incheon		Korea, Republic of

Sponsors and Collaborators

• Celltrion

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jul 27, 2020
• Statistical Analysis Plan - Apr 14, 2021

More Information

Publications

None provided.

• Responsible Party: Celltrion
• ClinicalTrials.gov Identifier: NCT04593641
• Other Study ID Numbers: CT-P59 1.2; 2020-003165-19
• First Posted: Oct 20, 2020
• Last Update Posted: Apr 8, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; COVID-19

Study Results

Participant Flow

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Period Title: Overall Study
STARTED	5	5	5	3
COMPLETED	4	5	5	3
NOT COMPLETED	1	0	0	0

Baseline Characteristics

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo	Total
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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 of all reporting groups
Overall Participants	5	5	5	3	18
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	5 100%	5 100%	3 100%	18 100%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	59	51	52	50	52
Sex: Female, Male (Count of Participants)
Female	3 60%	3 60%	0 0%	1 33.3%	7 38.9%
Male	2 40%	2 40%	5 100%	2 66.7%	11 61.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	5 100%	5 100%	5 100%	3 100%	18 100%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	5 100%	0 0%	0 0%	1 33.3%	6 33.3%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	0 0%	5 100%	5 100%	2 66.7%	12 66.7%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
South Korea	5 100%	0 0%	0 0%	1 33.3%	6 33.3%
Romania	0 0%	5 100%	5 100%	2 66.7%	12 66.7%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With TEAEs
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	3 60%	4 80%	3 60%	1 33.3%

2. Primary Outcome

Title	Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Safety set

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Safety set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)
Time Frame	Up to Day 14

Outcome Measure Data

Analysis Population Description

Safety set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
Time Frame	At Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
The number of patients with negative for qPCR	4 80%	4 80%	2 40%	2 66.7%
The number of patients with positive for qPCR	1 20%	1 20%	2 40%	1 33.3%
The number of patients who did not obtain any result for qPCR	0 0%	0 0%	1 20%	0 0%

6. Secondary Outcome

Title	Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Mean (Standard Deviation) [days]	17.49 (6.891)	12.50 (10.194)	18.51 (9.344)	14.19 (11.879)

7. Secondary Outcome

Title	Area Under the Concentration-time Curve of Viral Titers for qPCR
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Mean (Standard Deviation) [(log10cp/mL)*days]	55.45 (15.964)	41.05 (38.738)	56.26 (28.358)	60.26 (60.062)

8. Secondary Outcome

Title	Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Actual results for viral shedding in nasopharyngeal swab specimens for qPCR at Day 28	0.382 (0.8542)	0.452 (1.0107)	1.008 (1.1665)	0.637 (1.1027)
Change from baseline for viral shedding in nasopharyngeal swab specimens for qPCR up to Day 28	-6.326 (0.9801)	-4.258 (1.8477)	-5.723 (1.6683)	-4.367 (1.0060)

9. Secondary Outcome

Title	Number of Patients With Clinical Recovery
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	5 100%	5 100%	5 100%	2 66.7%

10. Secondary Outcome

Title	Number of Patients Requiring Supplemental Oxygen
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	3 60%	0 0%	0 0%	1 33.3%

11. Secondary Outcome

Title	Number of Patients With Intensive Care Unit Transfer
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

12. Secondary Outcome

Title	Number of Mechanical Ventilation
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

13. Secondary Outcome

Title	Number of Patients With All-cause Mortality
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	0 0%	0 0%	0 0%	0 0%

14. Secondary Outcome

Title	Number of Patients With Hospital Admission
Time Frame	Up to Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg	Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.	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.
Measure Participants	5	5	5	3
Count of Participants [Participants]	0 0%	0 0%	0 0%	1 33.3%

15. Secondary Outcome

Title	Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59
Description	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).
Time Frame	Up to Day 90

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
Measure Participants	5	5	5
Mean (Standard Deviation) [hr*ng/mL]	84538893.8 (10202293.97)	178065255.1 (16390524.47)	433826801.0 (112102013.80)

16. Secondary Outcome

Title	Time to Cmax (Tmax) of CT-P59
Description	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).
Time Frame	Up to Day 90

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
Measure Participants	5	5	5
Median (Full Range) [hr]	2.500	2.500	2.500

17. Secondary Outcome

Title	Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose)
Description	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).
Time Frame	Up to Day 90

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
Measure Participants	5	5	5
Mean (Standard Deviation) [hr*ng/mL/mg]	62595.7 (7539.48)	58838.6 (10090.23)	60936.0 (11969.30)

18. Secondary Outcome

Title	Terminal Half-life (t1/2) of CT-P59
Description	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).
Time Frame	Up to Day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
Measure Participants	5	5	5
Mean (Standard Deviation) [hr]	357.1 (41.06)	380.8 (25.35)	496.3 (133.26)

19. Secondary Outcome

Title	Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59
Description	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).
Time Frame	Up to Day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
Measure Participants	5	5	5
Mean (Standard Deviation) [Percentage of the extrapolated area]	5.917 (10.073)	1.242 (0.48091)	3.953 (2.2905)

20. Secondary Outcome

Title	Terminal Elimination Rate Constant (λz) of CT-P59
Description	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).
Time Frame	Up to Day 90

Outcome Measure Data

Analysis Population Description

Pharmacokinetic (PK) set.

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
Measure Participants	5	5	5
Mean (Standard Deviation) [1/hr]	0.00196 (0.00024353)	0.001827 (0.00012290)	0.001493 (0.00046237)

21. Secondary Outcome

Title	Total Body Clearance (CL) of CT-P59
Description	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).
Time Frame	Up to Day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
Measure Participants	5	5	5
Mean (Standard Deviation) [mL/hr]	16.18 (2.0775)	17.46 (3.4120)	16.86 (2.8482)

22. Secondary Outcome

Title	Volume of Distribution During the Elimination Phase (Vz) of CT-P59
Description	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).
Time Frame	Up to Day 90

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	CT-P59 20 mg/kg	CT-P59 40 mg/kg	CT-P59 80 mg/kg
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.	Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.
Measure Participants	5	5	5
Mean (Standard Deviation) [mL]	8351.9 (1676.84)	9514.7 (1357.53)	11968.2 (3725.56)

Adverse Events

Time Frame	Adverse events were assessed from the date the patients signed the ICF until end-of-treatment visit (up to Day 90).
Adverse Event Reporting Description	Treatment Period: Day 1 to Day 90
Arm/Group Title	CT-P59 20 mg/kg		CT-P59 40 mg/kg		CT-P59 80 mg/kg		Placebo
Arm/Group Description	Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1.		Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1.		Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1.		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.
All Cause Mortality
	CT-P59 20 mg/kg		CT-P59 40 mg/kg		CT-P59 80 mg/kg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/3 (0%)
Serious Adverse Events
	CT-P59 20 mg/kg		CT-P59 40 mg/kg		CT-P59 80 mg/kg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/5 (0%)		0/5 (0%)		0/3 (0%)
Other (Not Including Serious) Adverse Events
	CT-P59 20 mg/kg		CT-P59 40 mg/kg		CT-P59 80 mg/kg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/5 (60%)		4/5 (80%)		3/5 (60%)		1/3 (33.3%)
Cardiac disorders
Palpitations	0/5 (0%)		1/5 (20%)		0/5 (0%)		0/3 (0%)
Eye disorders
Conjunctival haemorrhage	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/3 (0%)
Gastrointestinal disorders
Diarrhoea	2/5 (40%)		0/5 (0%)		0/5 (0%)		0/3 (0%)
Dysphagia	0/5 (0%)		1/5 (20%)		0/5 (0%)		0/3 (0%)
Hepatobiliary disorders
Hepatocellular injury	0/5 (0%)		1/5 (20%)		0/5 (0%)		0/3 (0%)
Infections and infestations
COVID-19 pneumonia	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/3 (33.3%)
Candida infection	0/5 (0%)		0/5 (0%)		1/5 (20%)		0/3 (0%)
Investigations
Alanine aminotransferase increased	0/5 (0%)		1/5 (20%)		1/5 (20%)		0/3 (0%)
Blood creatine phosphokinase increased	0/5 (0%)		0/5 (0%)		1/5 (20%)		0/3 (0%)
Metabolism and nutrition disorders
Hypertriglyceridaemia	0/5 (0%)		1/5 (20%)		0/5 (0%)		0/3 (0%)
Musculoskeletal and connective tissue disorders
Flank pain	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/3 (0%)
Psychiatric disorders
Insomnia	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/3 (0%)
Respiratory, thoracic and mediastinal disorders
Productive cough	1/5 (20%)		0/5 (0%)		0/5 (0%)		0/3 (0%)
Vascular disorders
Hypertension	0/5 (0%)		0/5 (0%)		0/5 (0%)		1/3 (33.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.