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-P63 in Healthy Subjects.
CT-P63 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS CoV 2 infection. CT-P63 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-P63 will be evaluated in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
Biokinetica S.A
Józefów, Poland
To evaluate safety and tolerability of single ascending dose of CT-P63:
1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs) by CTCAE v5.0 2. Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs) by CTCAE v5.0 3. Proportion of patients with TEAEs of special interest (IRR including hypersensitivity/anaphylactic reaction) by CTCAE v5.0
Time frame: Up to 14 Days
To evaluate immunogenicity of single ascending dose of CT-P63:
Incidence of ADA and NAbs to CT-P63 (positive or negative)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
Pharmacokinetic (PK) parameter: Area under the serum concentration-time curve from time zero to infinity, calculated using the linear up and low down trapezoidal rule(AUC0-inf)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Dose normalized AUC0-inf (normalized to total body dose)(AUC0-inf/Dose)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Area under the serum concentration-time curve from time zero to the last quantifiable concentration, calculated using the linear up and log down trapezoidal rule(AUC0-last)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Dose normalized AUC0-last (normalized to total body dose)(AUC0-last/Dose)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
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PK parameter: Maximum observed serum concentration(Cmax)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Dose normalized Cmax(normalized to total body dose)(Cmax/Dose)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Time to Cmax(Tmax)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Terminal elimination half-life(t1/2)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Percentage of the area extrapolated for calculation of AUC0-inf(%AUCext)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Terminal elimination rate constant estimated from the linear regression of the natural log-transformed concentration over time at the terminal phase(λz)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Total body clearance(CL)
Time frame: Up to 90 Days
To evaluate the Pharmacokinetic(PK) of CT-P63
PK parameter: Volume of distribution at steady state (Vss)
Time frame: Up to 90 Days