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

September 30, 2024 updated by: AstraZeneca

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Adverse Events of Special Interest
Time Frame: recorded from the time of signature of the ICF up to 245 days
Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.
recorded from the time of signature of the ICF up to 245 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Concentrations of AZD7442 Over Time
Time Frame: recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.
Serum concentrations for each scheduled time point are summarized based on the PK Analyses Set using descriptive statistics
recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

November 21, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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