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)

Phase 1

Completed

Conditions: SARS-CoV-2 Infection

Interventions: Biological: CT-P59

Registration Number: NCT04593641

Lead Sponsor: Celltrion

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 18

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:
1. Oxygen saturation ≥ 94% on room air.
2. Not requiring supplemental oxygen.
Onset of symptom is no more than 7 days prior to the study drug administration.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 3 will receive a dose of CT-P59 or matching placebo	CT-P59	Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59
Cohort 1 will receive a dose of CT-P59 or matching placebo	CT-P59	Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59
Cohort 2 will receive a dose of CT-P59 or matching placebo	CT-P59	Drug: CT-P59 CT-P59 will be administered Drug: Placebo Placebo-matching CT-P59

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Number of Patients Requiring Supplemental Oxygen	Up to Day 28
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).
Number of Patients With All-cause Mortality	Up to Day 28
Number of Patients With Clinical Recovery	Up to Day 28
Number of Mechanical Ventilation	Up to Day 28
The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR)	At 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 Intensive Care Unit Transfer	Up to Day 28
Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR	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).
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).
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).
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).
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).
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).
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).
Number of Patients With Hospital Admission	Up to Day 28