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)

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

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.

Study Overview

• Status: Completed
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Biological: CT-P59

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Incheon Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Collaborators and Investigators

• Sponsor: Celltrion

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Actual): October 26, 2020
• Study Completion (Actual): April 5, 2021

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 20, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• Other Study ID Numbers: CT-P59 1.2; 2020-003165-19 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No