A Phase 1 study to Evaluate the Safety, Tolerability and Virology of CT-P59 in Patient with Mild COVID-19

Treatment

Test Drug Formulation, Dose, and Regimen: 
CT-P59 (960 mg/16 mL): 20 mg/kg, 40 mg/kg or 80 mg/kg, intravenous (IV) infusion for 90 minutes (±15 minutes)

Reference Drug Formulation, Dose, and Regimen:
Placebo (16 mL): matching in volume to each dose of CT-P59, IV infusion for 90 minutes (±15 minutes)

Arm Label

Target Number of Participant

Arm Type

Arm Description

CT-P59 will be administrated.
Subjects are randomized into 5:1 ratio.
Intravenous infusion, single dose

Arm Label

Target Number of Participant

Arm Type

Arm Description

Placebo will be administrated. 
Subjects are randomizaed into 5:1 ratio.
Intravenous infusion, single dose

Gender

Age

Description

• mild COVID-19 infection diagnosed by RT-PCR. 
• no more than 7 days prior to the study drug administration from the onset of symptoms

• History of and/or current infection with human immunodeficiency virus or current infection with hepatitis B or hepatitis C 
• Any conditions suspected of being moderate/severe symptoms of SARS-CoV-2 infection, in the opinion of the Investigator

Treatment-emergent adverse events

Up to Day 14

Potential effects on the incidence of antibody-dependent enhancement

Up to Day 14

Clinical laboratory test(clinical chemistry, hematology, and urinalysis)

Up to Day 14

This study was a randomized, double-blind, placebo-controlled, parallel group, single ascending dose, Phase 1, pilot study to evaluate the safety, tolerability, and virology of CT-P59 in patients with mild symptoms of SARS-CoV-2 infection.
Overall, 20 treatment-emergent adverse events (TEAEs) considered to be unrelated to the study drug were reported in 11 (61.1%) patients, with a similar proportion of patients who experienced at least 1 TEAE among the CT-P59 treatment groups (3 [60%], 4 [80%], and 3 [60%] in the CT-P59 20 mg/kg, CT-P59 40 mg/kg and CT-P59 80 mg/kg treatment groups, respectively) and 1 (33.3%) patient in the Placebo group. No deaths, TESAEs, TEAEs leading to permanent study drug discontinuation and TEAESIs classified as infusion related reactions were reported during the study. There were no clinically notable abnormalities reported from other safety assessments, including vital signs, hypersensitivity monitoring, 12-lead electrocardiogram, physical examination, SARS-CoV-2 infection related signs and symptoms and antibody-dependent enhancement following study drug administration.
Viral shedding in nasopharyngeal swab specimens based on quantitative polymerase chain reaction (qPCR) was analyzed. Overall, the mean changes from baseline for viral shedding based on qPCR were generally greater in the CT-P59 treatment groups than the Placebo group. In the case of patients with maximum viral titer over 5 log10cp/mL, greater reductions in viral shedding were observed after receiving CT-P59 than Placebo up to Day 10, suggesting the antiviral effect of CT-P59 in patients with mild symptoms of SARS-CoV-2 infection.
As qualifying sequencing data using Illumina MiSeq method, no significant genetic variations for amino acid of SARS-CoV-2 receptor-binding domain were observed after study drug administration.
The proportion of patients achieving clinical recovery up to Day 28 was higher in the CT-P59 treatment groups compared to Placebo group. Patient without clinical recovery up to Day 28 was only reported in the Placebo group. There was only 1 (5.6%) patient in the Placebo group who was hospitalized and requiring supplemental oxygen due to deterioration of SARS-CoV-2 infection. There were no patients with intensive care unit transfer, mechanical ventilation use and death cases in this study.
The overall shape of mean serum concentrations of CT-P59 showed that the higher the administered dose (CT-P59 20 mg/kg, 40 mg/kg, and 80 mg/kg), the higher the mean serum concentration at all-time points following a single IV infusion after start of the study drug administration. The median values of Tmax were 2.50 hours for CT-P59 20 mg/kg, CT-P59 40 mg/kg and CT-P59 80 mg/kg treatment groups, respectively. The geometric mean values of t1/2 were 355.1 hours, 380.2 hours and 480.8 hours for CT-P59 20 mg/kg, CT-P59 40 mg/kg and CT-P59 80 mg/kg treatment groups, respectively. Based on the statistical analysis of dose proportionality of CT-P59, the increase in Cmax, AUC0-last, and AUC0-inf of CT-P59 was slightly greater than dose proportional over the studied dose range of 20 to 80 mg/kg in patients with mild symptoms of SARS-CoV-2 infection.