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

CompletedPhase 2

Sponsor: AstraZeneca

Conditions: Coronavirus Disease 2019 (COVID-19)

Interventions: 600 mg AZD7442 IV, 600mg placebo IV

Countries: China

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Adults ≥ 18 years
2. Negative results of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) quantitative reverse transcriptase polymerase chain reaction (qRT-PCR)
3. Healthy or medically stable participants
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) \> 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.
3. COVID-19 infection history/any receipt of mAb indicated for COVID-19.
4. Prior/concomitant treatment: Receipt of any investigational product within 90 days or 5 antibody half-lives (whichever is longer) prior to Day 1

Locations (14)

Baoding, China
Beijing, China
Changsha, China
Chongqing, China
Fuzhou, China
Haikou, China
Hangzhou, China
Lanzhou, China
Shanghai, China
Shanghai, China
Shanghai, China
Suzhou, China
Ürümqi, China
Xuzhou, China