This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group, Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects.
CT-P59 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD 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 pharmacokinetics of CT-P59 will be evaluated in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Enrollment
32
Chungnam National University Hospital
Daejeon, South Korea
Preliminary Safety and Tolerability of CT-P59
A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.
Time frame: Up to Day 14 after the subject administered with the study drug (Day 1)
Additional Safety of CT-P59 Including Immunogenicity
A TEAE includes any untoward medical occurrence in a subject after administration of a study drug, which does not necessarily have to have a causal relationship with this the study drug.
Time frame: Up to 90 Days
Pharmacokinetic (PK) Parameters: AUC0-inf and AUC0-last
Data contain Area under the serum concentration-time curve (AUC) from time zero to infinity (AUC0-inf) and Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P59.
Time frame: Up to 90 Days
Pharmacokinetic (PK) Parameters: AUC0-inf/Dose and AUC0-last/Dose
Data contain Dose normalized AUC0-inf (AUC0-inf/Dose) and Dose normalized AUC0-last (AUC0-last/Dose)
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Cmax
Data contains Maximum observed serum concentration(Cmax) of CT-P59
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Cmax/Dose
Data contains Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Tmax
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Data indicates Time to Cmax(Tmax) of CT-P59
Time frame: Up to 90 Days
Pharmacokinetic (PK) Parameter: t1/2
Data contains Terminal half-life (t1/2) of CT-P59
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: %AUCext
Data contains Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: λz
Data contains Terminal elimination rate constant (λz) of CT-P59
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: CL
Data contains Total body clearance (CL) of CT-P59
Time frame: Up to Day 90
Pharmacokinetic (PK) Parameter: Vz
Data contains Volume of distribution during the elimination phase (Vz) of CT-P59
Time frame: Up to Day 90