Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults
Lead Sponsor:
AstraZeneca
Conditions:
Coronavirus Disease 2019 (COVID-19)
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo
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, approxim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2023
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT05437289
Start Date
October 9 2021
End Date
January 16 2023
Last Update
March 31 2023
Active Locations (2)
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1
Research Site
Guangzhou, China, 510515
2
Research Site
Shanghai, China, 201107