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.
'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.
Biological: CT-P59
administered
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.
Incheon Medical Center
Incheon, Korea, Republic of