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)

Study Overview
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Brief Summary
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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
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'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.

Official Title
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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

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Biological: CT-P59


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1 will receive a dose of CT-P59 or matching placebo<br>Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59 | Biological: CT-P59<br>* administered<br>|
| Experimental: Cohort 2 will receive a dose of CT-P59 or matching placebo<br>Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59 | Biological: CT-P59<br>* administered<br>|
| Experimental: Cohort 3 will receive a dose of CT-P59 or matching placebo<br>Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59 | Biological: CT-P59<br>* administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Number of Patients With Hospital Admission |  | Up to Day 28 | 
| 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). | Up to Day 90 | 
| 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). | Up to Day 90 | 
| 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). | Up to Day 90 | 
| 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). | Up to Day 90 | 
| 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). | Up to Day 90 | 
| 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). | Up to Day 90 | 
| 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). | Up to Day 90 | 
| 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). | Up to Day 90 |