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AZD7442Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug1284 Hydroxychloroquine Wiki 0.10
drug2122 Placebo Wiki 0.05

Correlated MeSH Terms (7)

Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.09
D012128 Respiratory Distress Syndrome, Adult NIH 0.08
D003141 Communicable Diseases NIH 0.08
D007239 Infection NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD7442 in Healthy Adults

In this first-in-humans dose escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs). The study is intended to enable future studies of AZD7442's efficacy in preventing and treating COVID-19.

NCT04507256 COVID-19 Combination Product: AZD7442 Other: Placebo

Primary Outcomes

Description: Safety and tolerability will be evaluated in terms of number of participants with AEs/SAEs, abnormal values of vital signs, safety laboratory parameters, 12 lead safety electrocardiogram, injection site reactions, and physical examination.

Measure: Number of participants with adverse events (AEs) and serious AEs

Time: From Day 1 to up to last follow-up day (Day 361)

Secondary Outcomes

Description: Cmax will be assessed after IV infusion of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Observed maximum concentration (Cmax) (IV infusion)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: Tmax will be assessed after IV infusion of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Time to reach maximum concentration (Tmax) (IV infusion)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: t½λz will be assessed after IV infusion of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Terminal elimination half life, estimated as (ln2)/λz (t½λz) (IV infusion)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: AUClast will be assessed after IV infusion of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Area under the concentration curve from time zero to the time of last quantifiable concentration (AUClast) (IV infusion)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: AUCinf will be assessed after IV infusion of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) (IV infusion)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: Vss will be assessed after IV infusion of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Volume of distribution at steady state (Vss) (IV infusion)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: Vz will be assessed after IV infusion of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Volume of distribution at terminal phase (Vz) (IV infusion)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: CL will be assessed after IV infusion of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Systemic clearance (CL) (IV infusion)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: Cmax will be assessed after IM injection of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Cmax (IM injection)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: Tmax will be assessed after IM injection of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Tmax (IM injection)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: t½λz will be assessed after IM injection of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: t½λz (IM injection)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: AUClast will be assessed after IM injection of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: AUClast (IM injection)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: AUCinf will be assessed after IM injection of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: AUCinf (IM injection)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: CL/F will be assessed after IM injection of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Extravascular systemic clearance (CL/F) (IM injection)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: F will be assessed after IM injection of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Bioavailability (F) (IM injection)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: Vz/F will be assessed after IM injection of AZD7442 using noncompartmental methods with Phoenix® WinNonlin® Version 8.1, or higher.

Measure: Extravascular terminal-phase volume of distribution (Vz/F) (IM injection)

Time: From Day 1 to up to last follow-up day (Day 361)

Description: The incidence of ADAs to AZD7442 in serum will be summarised by number and percentage of participants who are ADA positive. The ADA titer will be listed by participant at different time points.

Measure: Number and percentage of participants who are ADA positive

Time: From Day 1 to up to last follow-up day (Day 361)

No related HPO nodes (Using clinical trials)