Status:
COMPLETED
Phase I Double-blind, Placebo-controlled Study of AZD7442
Lead Sponsor:
AstraZeneca
Conditions:
COVID-19
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD7442.
Detailed Description
Severe acute respiratory coronavirus 2 is a novel coronavirus that appears to have first emerged in China in November 2019 causing cases of atypical pneumonia. Since then, the COVID-19 pandemic has ca...
Eligibility Criteria
Inclusion
- Participants must be Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Negative results from both SARS-CoV-2 qRT-PCR and serology tests
- Healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators
Exclusion
- Fever above 37.5°C by the time when the participant is randomised; a participant excluded for transient acute illness may be dosed if the illness resolves by the time of randomisation.
- History of infection with SARS or MERS
- Any drug therapy within 7 days prior to Day 1
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04896541
Start Date
March 16 2021
End Date
June 14 2022
Last Update
June 27 2022
Active Locations (1)
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1
Research Site
Fukuoka, Japan, 812-0025