Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
This randomized, double-blind, placebo controlled, study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. The study will be conducted in 2 parts. In Part A of this study, subjects will be randomized to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design. In Part B of this study, subjects will be randomized to receive up to 6 repeat doses of ST-2427 or placebo, administered twice-daily (BID) every 12 hours, in a Multiple Ascending Dose (MAD) design. In Part A and Part B, study drug (ST-2427 or placebo) will be administered intravenously (IV) over 1 hour. A total of 48 subjects will be enrolled. Subjects will be randomized in a 4:2 ratio of ST-2427 to placebo. Study drug will be blinded to all subjects and investigators.
Description: For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.
Measure: Incidence and severity of treatment-emergent adverse events Time: Day 1 through Day 8Description: Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure [DBP], systolic blood pressure [SBP], will be used to analyze for change from baseline.
Measure: Incidence and severity of adverse events assessed by blood pressure Time: Day 1 through Day 8Description: Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections, using concentration-QTc analysis, and on other ECG parameters (heart rate, PR and QRS interval and treatment emergent T and U-wave abnormalities).
Measure: Incidence and severity of adverse events assessed by ECG Time: Day 1 through Day 8Description: The Holter recordings will also be analyzed for the presence of arrhythmias and for derivation of heart rate variability (HRV).
Measure: Incidence and severity of adverse events assessed by Continous Holter Monitoring Time: Day 1 through Day 8Description: Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.
Measure: Incidence and severity of treatment-emergent events assessed by clinical laboratory assessments Time: Day 1 through Day 8Description: Body weight (kg) will be assessed for changes relative to baseline.
Measure: Incidence and severity of adverse events assessed by body weight Time: Day 1 through Day 8Description: PK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD, and after the first and fifth infusions of ST-2427 in the MAD will be measured.
Measure: Pharmacokinetics of ST-2427 concentration in whole blood: Cmax Time: Day 1 through Day 5Description: PK modeling will be performed using compartmental methods. The elimination half-life of ST-2427 in whole blood after the ST-2427 infusion in the SAD, and after the first and fifth infusions of ST-2427 in the MAD will be measured.
Measure: Pharmacokinetics of ST-2427 concentration in whole blood: Elimination half-life Time: Day 1 through Day 5Description: PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD, and after the first and fifth infusions of ST-2427 in the MAD will be measured.
Measure: Pharmacokinetics of ST-2427 concentration in whole blood: Area under the curve Time: Day 1 through Day 5Description: The ST-2427 concentrations in the urine will be measured in 4 hour increments by cohort for the SAD.
Measure: Pharmacokinetics of ST-2427 concentration in urine Time: Day 1 through Day 5Alphabetical 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