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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04593641
Other study ID # CT-P59 1.2
Secondary ID 2020-003165-19
Status Completed
Phase Phase 1
First received
Last updated
Start date September 4, 2020
Est. completion date April 5, 2021

Study information

Verified date April 2022
Source Celltrion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 18
Est. completion date April 5, 2021
Est. primary completion date October 26, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
CT-P59
administered

Locations

Country Name City State
Korea, Republic of Incheon Medical Center Incheon

Sponsors (1)

Lead Sponsor Collaborator
Celltrion

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients With TEAEs Up to Day 14
Primary Number of Patients With Treatment-Emergent Serious Adverse Events (TESAEs) Up to Day 14
Primary Number of Patients With Treatment-Emergent Adverse Events of Special Interest (TEAESI; Infusion Related Reactions Including Hypersensitivity/Anaphylactic Reaction) Up to Day 14
Primary Number of Patients With Potential Effects on the Incidence of Antibody-Dependent Enhancement (ADE) Up to Day 14
Secondary The Percentage of Patients With Positive/Negative for Quantitative Polymerase Chain Reaction (qPCR) At Day 28
Secondary Duration of Viral Shedding in Nasopharyngeal Swab Specimens for qPCR Up to Day 28
Secondary Area Under the Concentration-time Curve of Viral Titers for qPCR Up to Day 28
Secondary Actual Results and Change From Baseline for Viral Shedding in Nasopharyngeal Swab Specimens for qPCR Up to Day 28
Secondary Number of Patients With Clinical Recovery Up to Day 28
Secondary Number of Patients Requiring Supplemental Oxygen Up to Day 28
Secondary Number of Patients With Intensive Care Unit Transfer Up to Day 28
Secondary Number of Mechanical Ventilation Up to Day 28
Secondary Number of Patients With All-cause Mortality Up to Day 28
Secondary Number of Patients With Hospital Admission Up to Day 28
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary Terminal Elimination Rate Constant (?z) 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
Secondary 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
Secondary 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
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