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 Pharmacokinetics of CT-P59 in Healthy Subjects.
Detailed description
CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD 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 pharmacokinetics of CT-P59 will be evaluated in healthy subjects.
Interventions
DRUGCT-P59
CT-P59 will be administered
DRUGPlacebo
Placebo-matching CT-P59
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
Each subject must meet all of the following criteria to be randomized in this study: 1. Subject is a healthy male or female subject, aged between 19 to 55 years (both inclusive). Health is defined as no clinically relevant abnormalities identified by Investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurements, 12-lead electrocardiogram (ECG) and clinical laboratory tests prior to the study drug administration. 2. Subject is confirmed as negative in SARS-CoV-2 infection test on screening and Day -1 visits. 3. Subject with a body weight of ≥ 50 kg and a body mass index between 18.0 and 29.9 kg/m2 (both inclusive). 4. Subject is able to understand and to comply with protocol requirements, instructions, and restrictions. 5. Subject voluntarily agrees to participate in this study and has given a written informed consent prior to undergoing any of the screening procedures.
Exclusion criteria
Subject meeting any of the following criteria will be excluded from the study: 1. Subject has a medical history or current presence of disease including one or more of the following(s): 1. History of or current allergic reaction such as asthma, urticaria, angioedema, and eczematous dermatitis considered as clinically significant in the Investigator's opinion or hypersensitivity including known or suspected clinically relevant drug hypersensitivity to any monoclonal antibody or any component of study drug 2. History of or current medical condition including gastrointestinal, renal, endocrine, neurologic, autoimmune, hepatic, hematological metabolic (including known diabetes mellitus), cardiovascular, or psychiatric condition classed as clinically significant by the Investigator 3. History of or any concomitant active malignancy 4. History of or current infection with human immunodeficiency, syphilis, hepatitis B or hepatitis C 5. History of or current infection requiring a course of systemic anti-infective that was completed within 28 days prior to the study drug administration or a serious infection (associated with hospitalization or which required IV antibiotics) within 6 months before the study drug administration 6. History of an illness within 28 days prior to the study drug administration that is identified as clinically significant by the Investigator or requires hospitalization 7. History of surgical intervention or an operation within 28 days prior to the study drug administration or plans to have a surgical procedure during the study period 2. Subject had a history of or concurrent use of medications including any prior therapy of following(s): 1. Prescription medication (excluding hormonal birth control), over-the-counter drug, dietary supplements or herbal remedies within 7 days or 5 half-lives (whichever is longer) prior to the study drug administration 2. Any vaccination within 4 weeks prior to the study drug administration 3. Treatment with any monoclonal antibody, fusion protein, or blood transfusion within 6 months or 5 half lives (which is longer) prior to the study drug administration or current use of biologics 4. Treatment with any other investigational drug within 6 months or 5 half lives (which is longer) prior to the study drug administration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Preliminary Safety and Tolerability of CT-P59 | Up to Day 14 after the subject administered with the study drug (Day 1) | A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Up to 90 Days | Data contain Area under the serum concentration-time curve (AUC) from time zero to infinity (AUC0-inf) and Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P59. |
| Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Up to Day 90 | Data contain Dose normalized AUC0-inf (AUC0-inf/Dose) and Dose normalized AUC0-last (AUC0-last/Dose) |
| Pharmacokinetic (PK) Parameter: Cmax | Up to Day 90 | Data contains Maximum observed serum concentration(Cmax) of CT-P59 |
| Pharmacokinetic (PK) Parameter: Cmax/Dose | Up to Day 90 | Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59 |
| Pharmacokinetic (PK) Parameter: Tmax | Up to 90 Days | Data indicates Time to Cmax(Tmax) of CT-P59 |
| Additional Safety of CT-P59 Including Immunogenicity | Up to 90 Days | A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug. |
| Pharmacokinetic (PK) Parameter: %AUCext | Up to Day 90 | Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59 |
| Pharmacokinetic (PK) Parameter: λz | Up to Day 90 | Data contains Terminal elimination rate constant (λz) of CT-P59 |
| Pharmacokinetic (PK) Parameter: CL | Up to Day 90 | Data contains Total body clearance (CL) of CT-P59 |
| Pharmacokinetic (PK) Parameter: Vz | Up to Day 90 | Data contains Volume of distribution during the elimination phase (Vz) of CT-P59 |
| Pharmacokinetic (PK) Parameter: t1/2 | Up to Day 90 | Data contains Terminal half-life (t1/2) of CT-P59 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CT-P59 10 mg/kg Healthy volunteers were administered CT-P59 (10 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. | 6 |
| CT-P59 20 mg/kg Healthy volunteers were administered CT-P59 (20 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. | 6 |
| CT-P59 40 mg/kg Healthy volunteers were administered CT-P59 (40 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. | 6 |
| CT-P59 80 mg/kg Healthy volunteers were administered CT-P59 (80 mg/kg) by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. | 6 |
| Placebo Healthy volunteers were administered Placebo by intravenously on Day 1. Single-dose was administered to the subjects and monitor up to Day 90. | 8 |
| Total | 32 |
Baseline characteristics
| Characteristic | CT-P59 10 mg/kg | 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 | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 32 Participants |
| Age, Continuous | 33.5 years | 23.5 years | 28.5 years | 21.5 years | 25 years | 24 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 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 | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 32 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 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 | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 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 | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment South Korea | 6 participants | 6 participants | 6 participants | 6 participants | 8 participants | 32 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 0 / 6 | 4 / 6 | 3 / 6 | 0 / 6 | 1 / 8 |
| serious Total, serious adverse events | 0 / 6 | 1 / 6 | 0 / 6 | 0 / 6 | 0 / 8 |
Outcome results
Primary
Preliminary Safety and Tolerability of CT-P59
A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.
Time frame: Up to Day 14 after the subject administered with the study drug (Day 1)
Population: Safety set: All subjects who receive a full or partial dose of the study drugs
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT-P59 10 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| CT-P59 10 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 0 Participants |
| CT-P59 10 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CT-P59 20 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CT-P59 20 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 2 Participants |
| CT-P59 20 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 0 Participants |
| CT-P59 40 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CT-P59 40 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| CT-P59 40 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 0 Participants |
| CT-P59 80 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| CT-P59 80 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 0 Participants |
| CT-P59 80 mg/kg | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| Placebo | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| Placebo | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| Placebo | Preliminary Safety and Tolerability of CT-P59 | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 1 Participants |
Secondary
Additional Safety of CT-P59 Including Immunogenicity
A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.
Time frame: Up to 90 Days
Population: Safety set: All subjects who receive a full or partial dose of the study drugs.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CT-P59 10 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| CT-P59 10 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CT-P59 10 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 0 Participants |
| CT-P59 10 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Anti-Drug Antibody (ADA) positive to CT-P59 | 0 Participants |
| CT-P59 20 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 4 Participants |
| CT-P59 20 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Anti-Drug Antibody (ADA) positive to CT-P59 | 0 Participants |
| CT-P59 20 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 1 Participants |
| CT-P59 20 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 0 Participants |
| CT-P59 40 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Anti-Drug Antibody (ADA) positive to CT-P59 | 0 Participants |
| CT-P59 40 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CT-P59 40 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 0 Participants |
| CT-P59 40 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 3 Participants |
| CT-P59 80 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 0 Participants |
| CT-P59 80 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| CT-P59 80 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Anti-Drug Antibody (ADA) positive to CT-P59 | 0 Participants |
| CT-P59 80 mg/kg | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 0 Participants |
| Placebo | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Anti-Drug Antibody (ADA) positive to CT-P59 | 0 Participants |
| Placebo | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events of Special Interest (TEAESI) | 1 Participants |
| Placebo | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) | 0 Participants |
| Placebo | Additional Safety of CT-P59 Including Immunogenicity | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
Secondary
Pharmacokinetic (PK) Parameter: %AUCext
Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59
Time frame: Up to Day 90
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameter: %AUCext | 3.834 Percentage of AUC0-inf | Standard Deviation 5.2035 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameter: %AUCext | 2.120 Percentage of AUC0-inf | Standard Deviation 1.6724 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameter: %AUCext | 1.478 Percentage of AUC0-inf | Standard Deviation 0.5977 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameter: %AUCext | 4.005 Percentage of AUC0-inf | Standard Deviation 2.3526 |
Secondary
Pharmacokinetic (PK) Parameter: CL
Data contains Total body clearance (CL) of CT-P59
Time frame: Up to Day 90
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameter: CL | 15.46 mL/hr | Standard Deviation 3.5045 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameter: CL | 14.98 mL/hr | Standard Deviation 3.6165 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameter: CL | 18.46 mL/hr | Standard Deviation 2.1285 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameter: CL | 17.20 mL/hr | Standard Deviation 2.2033 |
Secondary
Pharmacokinetic (PK) Parameter: Cmax
Data contains Maximum observed serum concentration(Cmax) of CT-P59
Time frame: Up to Day 90
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameter: Cmax | 233166.7 ng/mL | Standard Deviation 37796.38 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameter: Cmax | 406333.3 ng/mL | Standard Deviation 43647.07 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameter: Cmax | 1020000.0 ng/mL | Standard Deviation 240084.15 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameter: Cmax | 1941666.7 ng/mL | Standard Deviation 267538.16 |
Secondary
Pharmacokinetic (PK) Parameter: Cmax/Dose
Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59
Time frame: Up to Day 90
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameter: Cmax/Dose | 307.1 ng/mL/mg | Standard Deviation 27.11 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameter: Cmax/Dose | 321.5 ng/mL/mg | Standard Deviation 45.42 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameter: Cmax/Dose | 337.0 ng/mL/mg | Standard Deviation 91.6 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameter: Cmax/Dose | 342.0 ng/mL/mg | Standard Deviation 44.74 |
Secondary
Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last
Data contain Area under the serum concentration-time curve (AUC) from time zero to infinity (AUC0-inf) and Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P59.
Time frame: Up to 90 Days
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P59 | 52469185.0 hr*ng/mL | Standard Deviation 20377788.54 |
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Area under the concentration-time curve from time 0 to the last measured concentration (AUC0-last) | 49593090.2 hr*ng/mL | Standard Deviation 15304853.54 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Area under the concentration-time curve from time 0 to the last measured concentration (AUC0-last) | 86246911.1 hr*ng/mL | Standard Deviation 15738302.53 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P59 | 88353384.1 hr*ng/mL | Standard Deviation 17775504.91 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P59 | 167086786.9 hr*ng/mL | Standard Deviation 21899708.77 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Area under the concentration-time curve from time 0 to the last measured concentration (AUC0-last) | 164581603.9 hr*ng/mL | Standard Deviation 21359705.9 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P59 | 335692549.3 hr*ng/mL | Standard Deviation 58444099.42 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last | Area under the concentration-time curve from time 0 to the last measured concentration (AUC0-last) | 321167775.4 hr*ng/mL | Standard Deviation 47167390.53 |
Secondary
Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose
Data contain Dose normalized AUC0-inf (AUC0-inf/Dose) and Dose normalized AUC0-last (AUC0-last/Dose)
Time frame: Up to Day 90
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Dose normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (normalized to total body dose) | 68774.1 hr*ng/mL/mg | Standard Deviation 22010.25 |
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Dose normalized AUC0-last (AUC0-last/Dose) of CT-P59 (normalized to total body dose) | 65200.8 hr*ng/mL/mg | Standard Deviation 15941.77 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Dose normalized AUC0-last (AUC0-last/Dose) of CT-P59 (normalized to total body dose) | 68847.6 hr*ng/mL/mg | Standard Deviation 18138.86 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Dose normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (normalized to total body dose) | 70620.6 hr*ng/mL/mg | Standard Deviation 20122.52 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Dose normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (normalized to total body dose) | 54763.5 hr*ng/mL/mg | Standard Deviation 6031.16 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Dose normalized AUC0-last (AUC0-last/Dose) of CT-P59 (normalized to total body dose) | 53932.1 hr*ng/mL/mg | Standard Deviation 5721.21 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Dose normalized AUC0-inf (AUC0-inf/Dose) of CT-P59 (normalized to total body dose) | 58981.8 hr*ng/mL/mg | Standard Deviation 7971.33 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose | Dose normalized AUC0-last (AUC0-last/Dose) of CT-P59 (normalized to total body dose) | 56474.7 hr*ng/mL/mg | Standard Deviation 6274.98 |
Secondary
Pharmacokinetic (PK) Parameter: t1/2
Data contains Terminal half-life (t1/2) of CT-P59
Time frame: Up to Day 90
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameter: t1/2 | 473.3 hr | Standard Deviation 181.26 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameter: t1/2 | 426.4 hr | Standard Deviation 84.52 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameter: t1/2 | 398.6 hr | Standard Deviation 36.3 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameter: t1/2 | 526.8 hr | Standard Deviation 106.62 |
Secondary
Pharmacokinetic (PK) Parameter: Tmax
Data indicates Time to Cmax(Tmax) of CT-P59
Time frame: Up to 90 Days
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameter: Tmax | 2.080 hr |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameter: Tmax | 1.575 hr |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameter: Tmax | 2.070 hr |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameter: Tmax | 2.430 hr |
Secondary
Pharmacokinetic (PK) Parameter: Vz
Data contains Volume of distribution during the elimination phase (Vz) of CT-P59
Time frame: Up to Day 90
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameter: Vz | 9848.9 mL | Standard Deviation 950.01 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameter: Vz | 8880.3 mL | Standard Deviation 907.1 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameter: Vz | 10532.2 mL | Standard Deviation 580.96 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameter: Vz | 12805.5 mL | Standard Deviation 937.08 |
Secondary
Pharmacokinetic (PK) Parameter: λz
Data contains Terminal elimination rate constant (λz) of CT-P59
Time frame: Up to Day 90
Population: Pharmacokinetic (PK) set: All subjects who receive a full dose of CT-P59 and have at least 1 evaluable post-treatment PK concentration result
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CT-P59 10 mg/kg | Pharmacokinetic (PK) Parameter: λz | 0.001586 1/hr | Standard Deviation 0.00038316 |
| CT-P59 20 mg/kg | Pharmacokinetic (PK) Parameter: λz | 0.001673 1/hr | Standard Deviation 0.00028913 |
| CT-P59 40 mg/kg | Pharmacokinetic (PK) Parameter: λz | 0.001751 1/hr | Standard Deviation 0.00016119 |
| CT-P59 80 mg/kg | Pharmacokinetic (PK) Parameter: λz | 0.001356 1/hr | Standard Deviation 0.00024242 |