A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
NCT ID: NCT05184062
Last Updated: 2024-11-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
272 participants
INTERVENTIONAL
2021-12-03
2023-05-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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AZD7442
co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion.
600 mg AZD7442 IV
Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.
Placebo
co-administration of a single dose of 600mg placebo by intravenous (IV) infusion.
600mg placebo IV
Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.
Interventions
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600 mg AZD7442 IV
Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.
600mg placebo IV
Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Baoding, , China
Research Site
Beijing, , China
Research Site
Changsha, , China
Research Site
Chongqing, , China
Research Site
Fuzhou, , China
Research Site
Haikou, , China
Research Site
Hangzhou, , China
Research Site
Lanzhou, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Shanghai, , China
Research Site
Suzhou, , China
Research Site
Ürümqi, , China
Research Site
Xuzhou, , China
Countries
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References
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Zhang J, Zhang H, Zhang Y, Liu S, Ge X, Zhang H, Li Y, Chen CC, Stepanov O, Tang W, Zhang W. Safety and Pharmacokinetics of Long-Acting Monoclonal Antibodies Tixagevimab and Cilgavimab (AZD7442) in a China Phase 2 Study and Evaluation of Asian Race Effect. Clin Pharmacol Drug Dev. 2025 Sep 5. doi: 10.1002/cpdd.1586. Online ahead of print.
Hirsch C, Park YS, Piechotta V, Chai KL, Estcourt LJ, Monsef I, Salomon S, Wood EM, So-Osman C, McQuilten Z, Spinner CD, Malin JJ, Stegemann M, Skoetz N, Kreuzberger N. SARS-CoV-2-neutralising monoclonal antibodies to prevent COVID-19. Cochrane Database Syst Rev. 2022 Jun 17;6(6):CD014945. doi: 10.1002/14651858.CD014945.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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D8850C00008
Identifier Type: -
Identifier Source: org_study_id
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