Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
Lead Sponsor:
AstraZeneca
Conditions:
Coronavirus Disease 2019 (COVID-19)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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).
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 6 2023
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT05184062
Start Date
December 3 2021
End Date
May 6 2023
Last Update
November 21 2024
Active Locations (14)
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1
Research Site
Baoding, China, 071000
2
Research Site
Beijing, China, 100034
3
Research Site
Changsha, China, 410008
4
Research Site
Chongqing, China, 400016