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Sections: Correlations,
Clinical Trials, and HPO
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There are 2 clinical trials
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.
Description: Proportion of patients with Treatment Emergent Adverse Events (TEAEs) Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs) Proportion of patients with TEAEs of special interest (IRR hypersensitivity/anaphylactic reaction
Measure: Primary safety outcome Time: Day 14Description: Proportion of patients with Treatment Emergent Adverse Events (TEAEs) Proportion of patients with Treatment Emergent Serious Adverse Events (TESAEs) Proportion of patients with TEAEs of special interest (IRR including hypersensitivity/anaphylactic reaction) Incidence of ADA and NAbs to CT-P59 (positive or negative)
Measure: To evaluate the safety of CT-P59 Time: Up to 90 DaysDescription: 1. 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) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 2. PK parameter: Dose normalized AUC0-inf (normalized to total body dose)(AUC0-inf/Dose) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 3. PK parameter: AUC from time zero to the last quantifiable concentration, calculated using the linear up and log down trapezoidal rule(AUC0-last) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 4. PK parameter: Dose normalized AUC0-last (normalized to total body dose)(AUC0-last/Dose) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 5. PK parameter: Maximum observed serum concentration(Cmax) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 6. PK parameter: Dose normalized Cmax(normalized to total body dose)(Cmax/Dose) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 7. PK parameter: Time to Cmax(Tmax) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 8. PK parameter: Terminal elimination half-life(t1/2) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 9. PK parameter: Percentage of the area extrapolated for calculation of AUC0-inf(%AUCext) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 10. PK parameter: Terminal elimination rate constant estimated from the linear regression of the natural log-transformed concentration over time at the terminal phase(λz) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 11. PK parameter: Total body clearance(CL) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysDescription: 12. PK parameter: Volume of distribution during the terminal phase(Vz) of CT-P59
Measure: To evaluate the Pharmacokinetic(PK) of CT-P59 Time: Up to 90 DaysThis 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: Primary safety outcome Proportion of patients with Treatment-Emergent Adverse Events (TEAEs) Proportion of patients with Treatment-Emergent Serious Adverse Events (TESAEs) Proportion of patients with Treatment-Emergent Adverse Events of Special Interest (TEAESI; infusion related reactions including hypersensitivity/anaphylactic reaction) Proportion of patients with potential effects on the incidence of Antibody-Dependent Enhancement (ADE)
Measure: To evaluate the preliminary safety and tolerability of CT-P59 up to Day 14 of the last enrolled subject Time: Up to Day 14Description: 1. The percentage of patients with positive/negative for quantitative Polymerase Chain Reaction (qPCR) and cell culture
Measure: To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates of CT-P59 Time: Up to Day 28Description: 2. Duration (days) of viral shedding in nasopharyngeal swab specimens for qPCR and cell culture
Measure: To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates of CT-P59 Time: Up to Day 28Description: 3. Area under the concentration-time curve of viral titers for qPCR and cell culture
Measure: To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates of CT-P59 Time: Up to Day 28Description: 4. Actual results and change from baseline for viral shedding in nasopharyngeal swab specimens (titers) for qPCR and cell culture
Measure: To evaluate the viral efficacy and characterization of SARS-CoV-2 viral isolates of CT-P59 Time: Up to Day 28Description: 1. Proportion of patients with clinical recovery
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 2. Proportion of patients requiring supplemental oxygen
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 3. Proportion of patients with intensive care unit transfer
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 4. Proportion of mechanical ventilation
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 5. Proportion of patients with all-cause mortality
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 6. Proportion of patients with hospital admission
Measure: To evaluate the efficacy of CT-P59 Time: Up to Day 28Description: 1. Pharmacokinetic (PK) parameter: Area under the concentration-time curve from time zero to infinity (AUC0-inf) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 2. Pharmacokinetic (PK) parameter: Dose normalized AUC0-inf (AUC0-inf/Dose) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 3. Pharmacokinetic (PK) parameter: Area under the concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 4. Pharmacokinetic (PK) parameter: Dose normalized AUC0-last (AUC0-last/Dose) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 5. Pharmacokinetic (PK) parameter: Time to Cmax (Tmax) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 6. Pharmacokinetic (PK) parameter: Terminal half-life (t1/2) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 7. Pharmacokinetic (PK) parameter: Percentage of AUC0-inf obtained by extrapolation (%AUCext) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 8. Pharmacokinetic (PK) parameter: Terminal elimination rate constant (λz) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 9. Pharmacokinetic (PK) parameter: Total body clearance (CL) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Description: 10. Pharmacokinetic (PK) parameter: Volume of distribution during the elimination phase (Vz) of CT-P59
Measure: To evaluate the Pharmacokinetics of CT-P59 Time: Up to Day 90Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports