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

March 30, 2023 updated by: AstraZeneca

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

To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in healthy Chinese participants 18 to 55 years of age, approximately 60 participants will be randomised in a 4:1 ratio to either AZD7442 or placebo, administered by intramuscular (IM) injection or intravenous (IV) infusion, and approximately 479 days in duration for each participant.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

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
      • Guangzhou, China, 510515
        • Research Site
      • Shanghai, China, 201107
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adults 18 to 55 years of age
  2. Healthy by medical history, physical examination, and baseline safety laboratory tests
  3. Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
  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) > upper limit of normal (ULN), or alkaline phosphatase (ALP) or TBL (total bilirubin) > 1.5 × ULN
    • Serum creatinine > ULN
    • Haemoglobin < lower limit normal (LLN)
    • Platelet count < LLN
    • White blood cell or neutrophil count outside normal reference ranges
    • 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.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 300 mg AZD7442 IM
Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection.
Drug: AZD7442 IM
In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections.
Other Names:
  • AZD7442
Drug: AZD7442 IM
In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections.
Other Names:
  • AZD7442
Placebo Comparator: 300mg placebo IM
Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.
Drug: Placebo IM
In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
Other Names:
  • Placebo
Drug: Placebo IM
In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
Other Names:
  • Placebo
Experimental: 600 mg AZD7442 IM
Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection.
Drug: AZD7442 IM
In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections.
Other Names:
  • AZD7442
Drug: AZD7442 IM
In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections.
Other Names:
  • AZD7442
Placebo Comparator: 600mg placebo IM
Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection.
Drug: Placebo IM
In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
Other Names:
  • Placebo
Drug: Placebo IM
In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
Other Names:
  • Placebo
Experimental: 300 mg AZD7442 IV
co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion.
Drug: AZD7442 IV
In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
Other Names:
  • AZD7442
Drug: AZD7442 IV
In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
Other Names:
  • Evusheld
Placebo Comparator: 300mg placebo IV
co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
Drug: Placebo IV
In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
Other Names:
  • Placebo
Drug: Placebo IV
In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
Other Names:
  • Placebo
Experimental: 600 mg AZD7442 IV
co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
Drug: AZD7442 IV
In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
Other Names:
  • AZD7442
Drug: AZD7442 IV
In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
Other Names:
  • Evusheld
Placebo Comparator: 600mg placebo IV
co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion.
Drug: Placebo IV
In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
Other Names:
  • Placebo
Drug: Placebo IV
In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events (AEs)
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
From day 1 to approximately 15 months after administration (through Day 451).
Incidence of serious adverse events (SAEs)
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
From day 1 to approximately 15 months after administration (through Day 451).
Incidence of adverse event of special interests (AESIs)
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of white blood cell (WBC) count, red blood cell (RBC) count.
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), calcium, phosphate, glucose, c-reactive protein (CRP).
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal Coagulation test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of prothrombin time, activated partial thrombin time (aPTT).
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal urinalysis
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of glucose, protein, and blood.
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal ECG readings
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Results for PR interval, QRS duration, QT interval, QTcF interval, and RR interval will be analyzed.
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal vital signs
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg).
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets, Reticulocytes absolute count.
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of haemoglobin (Hb).
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of haematocrit (HCT).
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of mean corpuscular volume (MCV).
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of mean corpuscular haemoglobin (MCH).
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), creatine kinase.
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of creatinine, total bilirubin, conjugated bilirubin.
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of albumin.
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal Coagulation test results
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of international normalised ratio (INR).
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal ECG readings
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Results for heart rate will be analyzed.
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal vital signs
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of pulse rate (beats per minute), respiratory rate (breaths per minute).
From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal vital signs
Time Frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of body temperature (in degree Celsius).
From day 1 to approximately 15 months after administration (through Day 451).

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 9, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D8850C00007

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

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 de-identified 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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