Back to resultsThis 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)
Primary Purpose
SARS-CoV-2 Infection
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CT-P59
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection
Eligibility Criteria
Inclusion Criteria:
Each patient must meet all of the following criteria to be randomized in this study:
- Adult male or female patient, aged between 18 to 60 years (both inclusive).
- Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
Patient has mild conditions meeting all of the following criteria:
- Oxygen saturation ≥ 94% on room air.
- Not requiring supplemental oxygen.
- 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:
- Respiratory distress with respiratory rate ≥ 30 breaths/min.
- Requires supplemental oxygen.
- Experience shock.
- Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
- 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.
Sites / Locations
- Incheon Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1 will receive a dose of CT-P59 or matching placebo
Cohort 2 will receive a dose of CT-P59 or matching placebo
Cohort 3 will receive a dose of CT-P59 or matching placebo
Arm Description
Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59
Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59
Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59
Outcomes
Primary Outcome Measures
Number of Patients With TEAEs
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)
Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction)
Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)
Secondary Outcome Measures
The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Area Under the Concentration-time Curve of Viral Titers for qPCR
Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Number of Patients With Clinical Recovery
Number of Patients Requiring Supplemental Oxygen
Number of Patients With Intensive Care Unit Transfer
Number of Mechanical Ventilation
Number of Patients With All-cause Mortality
Number of Patients With Hospital Admission
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 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).
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).
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).
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).
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).
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).
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04593641
Brief Title
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)
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
October 26, 2020 (Actual)
Study Completion Date
April 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1 will receive a dose of CT-P59 or matching placebo
Arm Type
Experimental
Arm Description
Drug: CT-P59
CT-P59 will be administered
Drug: Placebo
Placebo-matching CT-P59
Arm Title
Cohort 2 will receive a dose of CT-P59 or matching placebo
Arm Type
Experimental
Arm Description
Drug: CT-P59
CT-P59 will be administered
Drug: Placebo
Placebo-matching CT-P59
Arm Title
Cohort 3 will receive a dose of CT-P59 or matching placebo
Arm Type
Experimental
Arm Description
Drug: CT-P59
CT-P59 will be administered
Drug: Placebo
Placebo-matching CT-P59
Intervention Type
Biological
Intervention Name(s)
CT-P59
Intervention Description
administered
Primary Outcome Measure Information:
Title
Number of Patients With TEAEs
Time Frame
Up to Day 14
Title
Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs)
Time Frame
Up to Day 14
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
Title
Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE)
Time Frame
Up to Day 14
Secondary Outcome Measure Information:
Title
The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)
Time Frame
At Day 28
Title
Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Time Frame
Up to Day 28
Title
Area Under the Concentration-time Curve of Viral Titers for qPCR
Time Frame
Up to Day 28
Title
Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR
Time Frame
Up to Day 28
Title
Number of Patients With Clinical Recovery
Time Frame
Up to Day 28
Title
Number of Patients Requiring Supplemental Oxygen
Time Frame
Up to Day 28
Title
Number of Patients With Intensive Care Unit Transfer
Time Frame
Up to Day 28
Title
Number of Mechanical Ventilation
Time Frame
Up to Day 28
Title
Number of Patients With All-cause Mortality
Time Frame
Up to Day 28
Title
Number of Patients With Hospital Admission
Time Frame
Up to Day 28
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
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
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
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
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
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
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Each patient must meet all of the following criteria to be randomized in this study:
Adult male or female patient, aged between 18 to 60 years (both inclusive).
Patient with laboratory confirmed SARS-CoV-2 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) at Screening.
Patient has mild conditions meeting all of the following criteria:
Oxygen saturation ≥ 94% on room air.
Not requiring supplemental oxygen.
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:
Respiratory distress with respiratory rate ≥ 30 breaths/min.
Requires supplemental oxygen.
Experience shock.
Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator's discretion.
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.
Facility Information:
Facility Name
Incheon Medical Center
City
Incheon
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
35713300
Citation
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Results Reference
derived
PubMed Identifier
34551869
Citation
Kim JY, Jang YR, Hong JH, Jung JG, Park JH, Streinu-Cercel A, Streinu-Cercel A, Sandulescu O, Lee SJ, Kim SH, Jung NH, Lee SG, Park JE, Kim MK, Jeon DB, Lee YJ, Kim BS, Lee YM, Kim YS. Safety, Virologic Efficacy, and Pharmacokinetics of CT-P59, a Neutralizing Monoclonal Antibody Against SARS-CoV-2 Spike Receptor-Binding Protein: Two Randomized, Placebo-Controlled, Phase I Studies in Healthy Individuals and Patients With Mild SARS-CoV-2 Infection. Clin Ther. 2021 Oct;43(10):1706-1727. doi: 10.1016/j.clinthera.2021.08.009. Epub 2021 Aug 23.
Results Reference
derived
PubMed Identifier
34473343
Citation
Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
Results Reference
derived
Learn more about this trial
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)
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