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

NCT05184062
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Phase
Phase 2
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Recruitment status
Completed
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Participants
272
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Lead sponsor
AstraZeneca
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Start date
2021-12-03
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Number of sites
14
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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).
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Short title
A Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
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Official title
A Phase II Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of AZD7442 in Chinese Adults
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2023-05-06
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First posted
2022-01-11
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Registry last updated
2024-11-21
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Primary completion date
2022-08-15
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Start date
2021-12-03
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Actual participants
272
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Participants
272
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Participant count basis
Actual
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Protocol amendments
3
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Number of sites
14
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
AstraZeneca
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05184062
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ClinicalTrials.gov ID
NCT05184062
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Other
Masking
Triple masking
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Adverse Events of Special Interest

    Timeframe: recorded from the time of signature of the ICF up to 245 days

    Adverse events of special interest are events of scientific and medical interest, specific to the further understanding of the study intervention safety profile, and require close monitoring and rapid communication by the investigators to the sponsor.

  1. Serum Concentrations of AZD7442 Over Time

    Timeframe: recorded from the time of signature of the ICF through the last participant contact. Protocol-specified timepoints include Pre-dose, Day 1, Day 8, Day 31, Day 61, Day 91, Day 181, Day 271, and Day 361.

    Serum concentrations for each scheduled time point are summarized based on the PK Analyses Set using descriptive statistics

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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

  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

Sources for eligibility
clinicaltrials.gov

  • Research SiteBaoding, China
  • Research SiteBeijing, China
  • Research SiteChangsha, China
  • Research SiteChongqing, China
  • Research SiteFuzhou, China
  • Research SiteHaikou, China
  • Research SiteHangzhou, China
  • Research SiteLanzhou, China
  • Research SiteShanghai, China
  • Research SiteShanghai, China
  • Research SiteShanghai, China
  • Research SiteSuzhou, China
  • Research SiteÜrümqi, China
  • Research SiteXuzhou, China
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (26)