SARS-CoV-2 Infection
Conditions
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.
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.
Interventions
BIOLOGICALCT-P59
administered
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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: 1. Oxygen saturation ≥ 94% on room air. 2. Not requiring supplemental oxygen. 4. 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: 1. Respiratory distress with respiratory rate ≥ 30 breaths/min. 2. Requires supplemental oxygen. 3. Experience shock. 4. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion. 5. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With TEAEs | Up to Day 14 |
| Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs) | Up to Day 14 |
| Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction) | Up to Day 14 |
| Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE) | Up to Day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR | Up to Day 28 | — |
| Number of Patients With Clinical Recovery | Up to Day 28 | — |
| Number of Patients Requiring Supplemental Oxygen | Up to Day 28 | — |
| Number of Patients With Intensive Care Unit Transfer | Up to Day 28 | — |
| Number of Mechanical Ventilation | Up to Day 28 | — |
| Number of Patients With All-cause Mortality | Up to Day 28 | — |
| 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). |
| Number of Patients With Hospital Admission | Up to Day 28 | — |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| 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). |
| The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) | At Day 28 | — |
| Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR | Up to Day 28 | — |
| Area Under the Concentration-time Curve of Viral Titers for qPCR | Up to Day 28 | — |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CT-P59 20 mg/kg Patients were administered CT-P59 (20 mg/kg) by IV infusion with standard of care on Day 1. | 5 |
| CT-P59 40 mg/kg Patients were administered CT-P59 (40 mg/kg) by IV infusion with standard of care on Day 1. | 5 |
| CT-P59 80 mg/kg Patients were administered CT-P59 (80 mg/kg) by IV infusion with standard of care on Day 1. | 5 |
| 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. | 3 |
| Total | 18 |
Baseline characteristics
| Characteristic | CT-P59 20 mg/kg | CT-P59 40 mg/kg | CT-P59 80 mg/kg | Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 18 Participants |
| Age, Continuous | 59 years | 51 years | 52 years | 50 years | 52 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 5 Participants | 3 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 0 Participants | 0 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 5 Participants | 5 Participants | 2 Participants | 12 Participants |
| Region of Enrollment Romania | 0 participants | 5 participants | 5 participants | 2 participants | 12 participants |
| Region of Enrollment South Korea | 5 participants | 0 participants | 0 participants | 1 participants | 6 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 0 Participants | 1 Participants | 7 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 5 Participants | 2 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 3 / 5 | 4 / 5 | 3 / 5 | 1 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 5 | 0 / 3 |
Outcome results
Primary
Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)
Time frame: Up to Day 14
Population: Safety set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE) | 0 Participants |
| CT-P59 40 mg/kg | Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE) | 0 Participants |
| CT-P59 80 mg/kg | Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE) | 0 Participants |
| Placebo | Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE) | 0 Participants |
Primary
Number of Patients With TEAEs
Time frame: Up to Day 14
Population: Safety set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Patients With TEAEs | 3 Participants |
| CT-P59 40 mg/kg | Number of Patients With TEAEs | 4 Participants |
| CT-P59 80 mg/kg | Number of Patients With TEAEs | 3 Participants |
| Placebo | Number of Patients With TEAEs | 1 Participants |
Primary
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
Population: Safety set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction) | 0 Participants |
| CT-P59 40 mg/kg | Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction) | 0 Participants |
| CT-P59 80 mg/kg | Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction) | 0 Participants |
| Placebo | Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction) | 0 Participants |
Primary
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: Up to Day 14
Population: Safety set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CT-P59 40 mg/kg | Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CT-P59 80 mg/kg | Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| Placebo | Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
Secondary
Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Time frame: Up to Day 28
Population: Intent-to-Treat (ITT) set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P59 20 mg/kg | 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 |
| CT-P59 20 mg/kg | 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 |
| CT-P59 40 mg/kg | 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 | -4.258 log10cp/mL | Standard Deviation 1.8477 |
| CT-P59 40 mg/kg | 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 | 0.452 log10cp/mL | Standard Deviation 1.0107 |
| CT-P59 80 mg/kg | 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 | 1.008 log10cp/mL | Standard Deviation 1.1665 |
| CT-P59 80 mg/kg | 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 | -5.723 log10cp/mL | Standard Deviation 1.6683 |
| Placebo | 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 | 0.637 log10cp/mL | Standard Deviation 1.1027 |
| Placebo | 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 | -4.367 log10cp/mL | Standard Deviation 1.006 |
Secondary
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59
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
Population: Pharmacokinetic (PK) set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 20 mg/kg | 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 |
| CT-P59 40 mg/kg | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59 | 178065255.1 hr*ng/mL | Standard Deviation 16390524.47 |
| CT-P59 80 mg/kg | Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CT-P59 | 433826801.0 hr*ng/mL | Standard Deviation 112102013.8 |
Secondary
Area Under the Concentration-time Curve of Viral Titers for qPCR
Time frame: Up to Day 28
Population: Intent-to-Treat (ITT) set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 20 mg/kg | Area Under the Concentration-time Curve of Viral Titers for qPCR | 55.45 (log10cp/mL)*days | Standard Deviation 15.964 |
| CT-P59 40 mg/kg | Area Under the Concentration-time Curve of Viral Titers for qPCR | 41.05 (log10cp/mL)*days | Standard Deviation 38.738 |
| CT-P59 80 mg/kg | Area Under the Concentration-time Curve of Viral Titers for qPCR | 56.26 (log10cp/mL)*days | Standard Deviation 28.358 |
| Placebo | Area Under the Concentration-time Curve of Viral Titers for qPCR | 60.26 (log10cp/mL)*days | Standard Deviation 60.062 |
Secondary
Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose)
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
Population: Pharmacokinetic (PK) set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 20 mg/kg | 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 |
| CT-P59 40 mg/kg | Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose) | 58838.6 hr*ng/mL/mg | Standard Deviation 10090.23 |
| CT-P59 80 mg/kg | Dose Normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (Normalized to Total Body Dose) | 60936.0 hr*ng/mL/mg | Standard Deviation 11969.3 |
Secondary
Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Time frame: Up to Day 28
Population: Intent-to-Treat (ITT) set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 20 mg/kg | Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR | 17.49 days | Standard Deviation 6.891 |
| CT-P59 40 mg/kg | Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR | 12.50 days | Standard Deviation 10.194 |
| CT-P59 80 mg/kg | Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR | 18.51 days | Standard Deviation 9.344 |
| Placebo | Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR | 14.19 days | Standard Deviation 11.879 |
Secondary
Number of Mechanical Ventilation
Time frame: Up to Day 28
Population: Intent-to-Treat (ITT) set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Mechanical Ventilation | 0 Participants |
| CT-P59 40 mg/kg | Number of Mechanical Ventilation | 0 Participants |
| CT-P59 80 mg/kg | Number of Mechanical Ventilation | 0 Participants |
| Placebo | Number of Mechanical Ventilation | 0 Participants |
Secondary
Number of Patients Requiring Supplemental Oxygen
Time frame: Up to Day 28
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Patients Requiring Supplemental Oxygen | 3 Participants |
| CT-P59 40 mg/kg | Number of Patients Requiring Supplemental Oxygen | 0 Participants |
| CT-P59 80 mg/kg | Number of Patients Requiring Supplemental Oxygen | 0 Participants |
| Placebo | Number of Patients Requiring Supplemental Oxygen | 1 Participants |
Secondary
Number of Patients With All-cause Mortality
Time frame: Up to Day 28
Population: Intent-to-Treat (ITT) set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Patients With All-cause Mortality | 0 Participants |
| CT-P59 40 mg/kg | Number of Patients With All-cause Mortality | 0 Participants |
| CT-P59 80 mg/kg | Number of Patients With All-cause Mortality | 0 Participants |
| Placebo | Number of Patients With All-cause Mortality | 0 Participants |
Secondary
Number of Patients With Clinical Recovery
Time frame: Up to Day 28
Population: Intent-to-Treat (ITT) set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Patients With Clinical Recovery | 5 Participants |
| CT-P59 40 mg/kg | Number of Patients With Clinical Recovery | 5 Participants |
| CT-P59 80 mg/kg | Number of Patients With Clinical Recovery | 5 Participants |
| Placebo | Number of Patients With Clinical Recovery | 2 Participants |
Secondary
Number of Patients With Hospital Admission
Time frame: Up to Day 28
Population: Intent-to-Treat (ITT) set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Patients With Hospital Admission | 0 Participants |
| CT-P59 40 mg/kg | Number of Patients With Hospital Admission | 0 Participants |
| CT-P59 80 mg/kg | Number of Patients With Hospital Admission | 0 Participants |
| Placebo | Number of Patients With Hospital Admission | 1 Participants |
Secondary
Number of Patients With Intensive Care Unit Transfer
Time frame: Up to Day 28
Population: Intent-to-Treat (ITT) set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CT-P59 20 mg/kg | Number of Patients With Intensive Care Unit Transfer | 0 Participants |
| CT-P59 40 mg/kg | Number of Patients With Intensive Care Unit Transfer | 0 Participants |
| CT-P59 80 mg/kg | Number of Patients With Intensive Care Unit Transfer | 0 Participants |
| Placebo | Number of Patients With Intensive Care Unit Transfer | 0 Participants |
Secondary
Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 20 mg/kg | Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59 | 5.917 Percentage of the extrapolated area | Standard Deviation 10.073 |
| CT-P59 40 mg/kg | Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59 | 1.242 Percentage of the extrapolated area | Standard Deviation 0.48091 |
| CT-P59 80 mg/kg | Percentage of AUC0-inf Obtained by Extrapolation (%AUCext) of CT-P59 | 3.953 Percentage of the extrapolated area | Standard Deviation 2.2905 |
Secondary
Terminal Elimination Rate Constant (λz) of CT-P59
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
Population: Pharmacokinetic (PK) set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 20 mg/kg | Terminal Elimination Rate Constant (λz) of CT-P59 | 0.00196 1/hr | Standard Deviation 0.00024353 |
| CT-P59 40 mg/kg | Terminal Elimination Rate Constant (λz) of CT-P59 | 0.001827 1/hr | Standard Deviation 0.0001229 |
| CT-P59 80 mg/kg | Terminal Elimination Rate Constant (λz) of CT-P59 | 0.001493 1/hr | Standard Deviation 0.00046237 |
Secondary
Terminal Half-life (t1/2) of CT-P59
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 20 mg/kg | Terminal Half-life (t1/2) of CT-P59 | 357.1 hr | Standard Deviation 41.06 |
| CT-P59 40 mg/kg | Terminal Half-life (t1/2) of CT-P59 | 380.8 hr | Standard Deviation 25.35 |
| CT-P59 80 mg/kg | Terminal Half-life (t1/2) of CT-P59 | 496.3 hr | Standard Deviation 133.26 |
Secondary
The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
Time frame: At Day 28
Population: Intent-to-Treat (ITT) set.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT-P59 20 mg/kg | The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) | The number of patients with negative for qPCR | 4 Participants |
| CT-P59 20 mg/kg | 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 |
| CT-P59 20 mg/kg | The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) | The number of patients with positive for qPCR | 1 Participants |
| CT-P59 40 mg/kg | The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) | The number of patients with negative for qPCR | 4 Participants |
| CT-P59 40 mg/kg | 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 |
| CT-P59 40 mg/kg | The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) | The number of patients with positive for qPCR | 1 Participants |
| CT-P59 80 mg/kg | The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) | The number of patients with positive for qPCR | 2 Participants |
| CT-P59 80 mg/kg | The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) | The number of patients with negative for qPCR | 2 Participants |
| CT-P59 80 mg/kg | 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 | 1 Participants |
| Placebo | The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) | The number of patients with negative for qPCR | 2 Participants |
| Placebo | 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 |
| Placebo | The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) | The number of patients with positive for qPCR | 1 Participants |
Secondary
Time to Cmax (Tmax) of CT-P59
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
Population: Pharmacokinetic (PK) set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT-P59 20 mg/kg | Time to Cmax (Tmax) of CT-P59 | 2.500 hr |
| CT-P59 40 mg/kg | Time to Cmax (Tmax) of CT-P59 | 2.500 hr |
| CT-P59 80 mg/kg | Time to Cmax (Tmax) of CT-P59 | 2.500 hr |
Secondary
Total Body Clearance (CL) of CT-P59
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 20 mg/kg | Total Body Clearance (CL) of CT-P59 | 16.18 mL/hr | Standard Deviation 2.0775 |
| CT-P59 40 mg/kg | Total Body Clearance (CL) of CT-P59 | 17.46 mL/hr | Standard Deviation 3.412 |
| CT-P59 80 mg/kg | Total Body Clearance (CL) of CT-P59 | 16.86 mL/hr | Standard Deviation 2.8482 |
Secondary
Volume of Distribution During the Elimination Phase (Vz) of CT-P59
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 20 mg/kg | Volume of Distribution During the Elimination Phase (Vz) of CT-P59 | 8351.9 mL | Standard Deviation 1676.84 |
| CT-P59 40 mg/kg | Volume of Distribution During the Elimination Phase (Vz) of CT-P59 | 9514.7 mL | Standard Deviation 1357.53 |
| CT-P59 80 mg/kg | Volume of Distribution During the Elimination Phase (Vz) of CT-P59 | 11968.2 mL | Standard Deviation 3725.56 |