A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults

Study Overview
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Brief Summary
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To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV (intravenous) to Chinese adults (including those with stable medical conditions).

Detailed Description
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A Phase II, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD7442 for administration to prevent and treat coronavirus disease 2019 (COVID-19) in Chinese adult participants (including healthy participants as well as participants with stable medical conditions), approximately 479 days in duration for each participant.

Official Title
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A Phase II Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults

Conditions
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Coronavirus Disease 2019 (COVID-19)

Intervention / Treatment
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* Drug: 600 mg AZD7442 IV
* Drug: 600mg placebo IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults ≥ 18 years Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) Healthy or medically stable participants Contraceptive within 365 days post dosing Exclusion Criteria: Medical condition: Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component. Acute illness including fever on the day prior to or day of dosing. Any other significant disease increase the risk to participant study. Laboratory related: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.0 × upper limit of normal (ULN), alkaline phosphatase (ALP) > 1.5 × ULN, or TBL (total bilirubin) > 1.5 × ULN (unless due to Gilbert's syndrome). Serum creatinine > 176 μmol/L. Haemoglobin < 10g/dL. Platelet count < 100 × 10^3/μL. White blood cell count < 3.5 × 10^3/μL or neutrophil count < 1.5 × 10^3/μL. Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results. COVID-19 infection history/any receipt of mAb indicated for COVID-19. Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD7442<br>co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion. | Drug: 600 mg AZD7442 IV<br>* Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.<br>* Other names: AZD7442;|
| Placebo Comparator: Placebo<br>co-administration of a single dose of 600mg placebo by intravenous (IV) infusion. | Drug: 600mg placebo IV<br>* Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) | To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age. | From day1 to 6 months after administration. | 
| Incidence of serious adverse events (SAEs) | To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age. | From day1 to 6 months after administration. | 
| Incidence of adverse event of special interests (AESIs) | To evaluate the safety and tolerability of a single dose of 600 mg AZD7442 administered IV to Chinese participants (including those with stable medical conditions) ≥ 18 years of age. | From day1 to 6 months after administration. | 
| Safety as determined by abnormality in haematology | Measurement of white blood cell (WBC) count, red blood cell (RBC) count, haemoglobin (Hb), haematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets, Reticulocytes absolute count. | From day1 to 6 months after administration. | 
| Safety as determined by abnormality in clinical chemistry | Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), creatinine, albumin, calcium, phosphate, glucose, c-reactive protein (CRP), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), total bilirubin, conjugated bilirubin, creatine kinase. | From day1 to 6 months after administration. | 
| Safety as determined by abnormality in urinalysis | Measurement of glucose, protein, blood and microscopy. | From day1 to 6 months after administration. | 
| Safety as determined by abnormality in Coagulation. | Measurement of international normalised ratio (INR), prothrombin time, activated partial thrombin time (aPTT). | From day1 to 6 months after administration. | 
| Incidence of abnormal 12-lead electrocardiogram (ECG) | Results for PR interval, QRS duration, QT interval, QTcF interval, RR interval, and heart rate will be analyzed. | From day1 to 6 months after administration. | 
| Safety as determined by abnormal vital signs (blood pressure, pulse rate, body temperature, and respiratory rate) | Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg), pulse rate (beats per minute), body temperature (in degree Celsius), respiratory rate (breaths per minute). | From day1 to 6 months after administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus, COVID-19, AZD7442