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

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

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).

Study Overview

• Status: Completed
• Conditions: Coronavirus Disease 2019 (COVID-19)
• Intervention / Treatment: Drug: 600 mg AZD7442 IV; Drug: 600mg placebo IV

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Baoding, China, 071000
    • Research Site
  • Beijing, China, 100034
    • Research Site
  • Changsha, China, 410008
    • Research Site
  • Chongqing, China, 400016
    • Research Site
  • Fuzhou, China, 350005
    • Research Site
  • Haikou, China, 570311
    • Research Site
  • Hangzhou, China, 310006
    • Research Site
  • Lanzhou, China, 730030
    • Research Site
  • Shanghai, China, 200080
    • Research Site
  • Shanghai, China, 200040
    • Research Site
  • Shanghai, China, 200120
    • Research Site
  • Suzhou, China, 215004
    • Research Site
  • Urumqi, China, 830054
    • Research Site
  • Xuzhou, China, 221000
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults ≥ 18 years
2. Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)
3. Healthy or medically stable participants
4. Contraceptive within 365 days post dosing

Exclusion Criteria:

1. 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.

2. 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.
3. COVID-19 infection history/any receipt of mAb indicated for COVID-19.
4. Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: AstraZeneca

Publications and helpful links

General Publications

• Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2021
• Primary Completion (Actual): August 15, 2022
• Study Completion (Actual): May 6, 2023

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; AZD7442
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections
• Other Study ID Numbers: D8850C00008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No