Phase 2
Completed N=272
A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
Coronavirus Disease 2019 (COVID-19)
Source: ClinicalTrials.gov NCT05184062 ↗
Enrolled (actual)
272
Serious AEs
3.3%
Results posted
Nov 2024
Primary outcomePrimary: Adverse Events of Special Interest — 0; 0 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events of Special Interest |
0; 0 | — |
| SECONDARY Serum Concentrations of AZD7442 Over Time |
0; 219.7; 136.1; 101.5; 74.60; 55.98 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05184062). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.