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NCT Number: NCT05184062

A 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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Baoding, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

600 mg AZD7442 IV

Drug

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

600mg placebo IV

Drug

Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.

Other names: Placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jan 11, 2022
Registry last updated
Nov 21, 2024

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

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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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