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Completed

NCT Number: NCT05437289

A Study to Evaluate the Safety and Tolerability 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

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Key information

Conditions

Coronavirus Disease 2019 (COVID-19) COVID-19 Coronaviridae Infections Coronavirus Infections Healthy Volunteer Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Guangzhou, China

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults 18 to 55 years of age
  • Healthy by medical history, physical examination, and baseline safety laboratory tests
  • Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
  • 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) > 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.

Treatment and study plan

AZD7442 IM

Drug

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

Placebo IM

Drug

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

AZD7442 IV

Drug

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

Placebo IV

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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).

  10. 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.

  11. 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).

  12. 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).

  13. 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).

  14. 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).

  15. 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.

  16. 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.

  17. 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.

  18. 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).

  19. 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.

  20. 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).

  21. 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).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Jun 29, 2022
Registry last updated
Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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