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

• Status: Active, not recruiting
• Trial end date: 2023-02-10
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca

Criteria

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.