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

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

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.

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.