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There is one clinical trial.
This first-time-in-human (FTIH) study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single doses of AZD3427 in healthy volunteers and multiple doses of AZD3427 in patients with heart failure (HF).
Description: Assessment of the safety and tolerability of single and multiple ascending doses of AZD3427.
Measure: Number of Participants Experiencing Adverse Events and Serious Adverse Events Time: Part A: Day 1 until Day 50 or Early termination visit (E/T); Part B: Day 1 until Day 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Maximum Observed Serum (peak) Drug Concentration (Cmax) of AZD3427 Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Area Under the Serum Concentration-time Curve from Zero to the Last Quantifiable Concentration (AUClast) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Area Under Serum Concentration-time Curve From Zero to Infinity (AUCinf) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Area Under the Serum Concentration-time Curve from Zero to 168 Hours Post-dose Administration (AUC0-168) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Time to Reach Peak or Maximum Observed Concentration or Response Following Drug Administration (tmax) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the PK of single and multiple ascending doses of AZD3427.
Measure: Half-life Associated with Terminal Slope (λz) of a Semi-logarithmic Concentration-time Curve (t½λz) Time: Part A: Day 1 (pre-dose, and 10 minutes [only for cohort 5a], 4hrs and 12hrs post-dose, and days 2, 3, 8, 15, 29, and Day 50 or E/T ; Part B: Day 1 (Pre-dose and post-dose), days 8, 15, 22, and 29 (pre-dose); and days 2, 3, 36, 57, 71 and 78 or E/TDescription: Evaluation of the immunogenicity of single and multiple ascending doses of AZD3427.
Measure: Number of Participants Testing Positive for the Presence of Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb) to AZD3427 Time: Part A: Day 1 (pre-dose), Days 15, 29, and 50 or E/T; Part B: Days 1, 15, 29 (Pre-dose), Days 57 and 78 or E/TDescription: Evaluation of the immunogenicity of single and multiple ascending doses of AZD3427.
Measure: Evaluation of Positive Anti-drug Antibodies Titer Time: Part A: Day 1 (pre-dose), Days 15, 29, and 50 or E/T; Part B: Days 1, 15, 29 (Pre-dose), Days 57 and 78 or E/TDescription: Evaluation of the immunogenicity of single and multiple ascending doses of AZD3427.
Measure: Evaluation of Neutralizing Antibodies Titer Time: Part A: Day 1 (pre-dose), Days 15, 29, and 50 or E/T; Part B: Days 1, 15, 29 (Pre-dose), Days 57 and 78 or E/TAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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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