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).
A Phase II, randomised, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD7442 for administration to prevent and treat coronavirus disease 2019 (COVID-19) in Chinese adult participants (including healthy participants as well as participants with stable medical conditions), approximately 479 days in duration for each participant.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
272
Participants will be randomized to receive co-administration of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by a single IV infusion.
Participants will be randomized to receive co-administration of 600mg placebo by a single IV infusion.
Research Site
Baoding, China
Research Site
Beijing, China
Research Site
Changsha, China
Research Site
Adverse Events of Special Interest
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.
Time frame: recorded from the time of signature of the ICF up to 245 days
Serum Concentrations of AZD7442 Over Time
Serum concentrations for each scheduled time point are summarized based on the PK Analyses Set using descriptive statistics
Time frame: 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.
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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
...and 4 more locations