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This Phase 1, first-in-human (FiH), single-ascending-dose (SAD) study, will assess the safety and tolerability and characterize the pharmacokinetics (PK) of AZD2693, following subcutaneous (SC) SAD administration of AZD2693 in male and female subjects of non-childbearing potential in overweight but otherwise healthy subjects, and healthy Chinese and Japanese subjects.
Description: To investigate the safety and tolerability of SC administration of SAD of AZD2693
Measure: Number of subjects experiencing adverse events and serious adverse events Time: From baseline (Day 1) until Day 112 (Week 16, Final follow-up)Description: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the concentration-time curve from time zero extrapolated to infinity (AUC) Time: At Day 1 pre-dose, 0.25 hours [h], 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC(0-48h)] Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUC/D) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Maximum observed plasma drug concentration (Cmax) of AZD2693 Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Observed maximum plasma concentration divided by the dose administered (Cmax/D) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Time to reach maximum observed concentration following drug administration (tmax) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693.
Measure: Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve, estimated as (ln2)/λz (t½λz) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Apparent total body clearance of drug from plasma after extravascular administration calculated as Dose/AUC (CL/F) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Apparent volume of distribution for parent drug at terminal phase (extravascular administration), estimated by dividing CL/F by λz (Vz/F) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Mean residence time (MRT) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Time delay between drug administration and the first observed concentration in plasma (tlag) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Time of the last quantifiable concentration (tlast) Time: At Day 1 pre-dose, 0.25h, 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 12h, 24h, 36h, 48h and 72h post-dose and 1, 2, 4, 8, 12 and 16 weeks post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Cumulative amount of analyte excreted into the urine from time zero through the last sampling interval [Ae(0-last)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC [CLR] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseDescription: To characterize the PK of AZD2693 following SC administration of SAD of AZD2693
Measure: Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)] Time: At Day 1 pre-dose, 0-6h, 6-12h and then 0-12h intervals up to 72h post-doseAlphabetical 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.
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