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

Primary Purpose

Coronavirus Disease 2019 (COVID-19)

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
600 mg AZD7442 IV
600mg placebo IV
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Coronavirus Disease 2019 (COVID-19) focused on measuring Coronavirus, COVID-19, AZD7442

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AZD7442

Placebo

Arm Description

co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.

co-administration of a single dose of 600mg placebo by intravenous (IV) infusion.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Safety as determined by abnormality in urinalysis
Measurement of glucose, protein, blood and microscopy.
Safety as determined by abnormality in Coagulation.
Measurement of international normalised ratio (INR), prothrombin time, activated partial thrombin time (aPTT).
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.
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).

Secondary Outcome Measures

Full Information

First Posted
November 17, 2021
Last Updated
May 17, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT05184062
Brief Title
A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
Official Title
A Phase II Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
December 3, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
May 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Disease 2019 (COVID-19)
Keywords
Coronavirus, COVID-19, AZD7442

7. Study Design

Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
272 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AZD7442
Arm Type
Experimental
Arm Description
co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
co-administration of a single dose of 600mg placebo by intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
600 mg AZD7442 IV
Other Intervention Name(s)
AZD7442
Intervention Description
Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.
Intervention Type
Drug
Intervention Name(s)
600mg placebo IV
Other Intervention Name(s)
Placebo
Intervention Description
Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
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.
Time Frame
From day1 to 6 months after administration.
Title
Incidence of serious adverse events (SAEs)
Description
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.
Time Frame
From day1 to 6 months after administration.
Title
Incidence of adverse event of special interests (AESIs)
Description
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.
Time Frame
From day1 to 6 months after administration.
Title
Safety as determined by abnormality in haematology
Description
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.
Time Frame
From day1 to 6 months after administration.
Title
Safety as determined by abnormality in clinical chemistry
Description
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.
Time Frame
From day1 to 6 months after administration.
Title
Safety as determined by abnormality in urinalysis
Description
Measurement of glucose, protein, blood and microscopy.
Time Frame
From day1 to 6 months after administration.
Title
Safety as determined by abnormality in Coagulation.
Description
Measurement of international normalised ratio (INR), prothrombin time, activated partial thrombin time (aPTT).
Time Frame
From day1 to 6 months after administration.
Title
Incidence of abnormal 12-lead electrocardiogram (ECG)
Description
Results for PR interval, QRS duration, QT interval, QTcF interval, RR interval, and heart rate will be analyzed.
Time Frame
From day1 to 6 months after administration.
Title
Safety as determined by abnormal vital signs (blood pressure, pulse rate, body temperature, and respiratory rate)
Description
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).
Time Frame
From day1 to 6 months after administration.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Research Site
City
Baoding
ZIP/Postal Code
071000
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Research Site
City
Changsha
ZIP/Postal Code
410008
Country
China
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Facility Name
Research Site
City
Haikou
ZIP/Postal Code
570311
Country
China
Facility Name
Research Site
City
Hangzhou
ZIP/Postal Code
310006
Country
China
Facility Name
Research Site
City
Lanzhou
ZIP/Postal Code
730030
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200120
Country
China
Facility Name
Research Site
City
Suzhou
ZIP/Postal Code
215004
Country
China
Facility Name
Research Site
City
Urumqi
ZIP/Postal Code
830054
Country
China
Facility Name
Research Site
City
Xuzhou
ZIP/Postal Code
221000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Citations:
PubMed Identifier
35713300
Citation
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.
Results Reference
derived

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

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