Recently, Fudan University professor Lu Hongzhou’s clinical trial of an effective drug neutralizing antibody "MW33 injection" for the prevention and treatment of new coronavirus infections showed that its safety, tolerability, and pharmacokinetic characteristics have a stable antibody structure.
In addition to vaccines, the new coronavirus neutralizing antibody is one of the generally recognized effective drugs for the prevention and treatment of new coronavirus infections
In order to further evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of single administration of "MW33 injection" in healthy subjects, and to provide data support for the smooth development of phase II-III clinical trials, After rigorous screening, the study finally enrolled 42 healthy volunteers, who were divided into 5 dose groups for climbing tests, namely, single injections of 4, 10, 20, 40, and 60 mg per kilogram of body weight were given.
In terms of pharmacokinetics, the half-lives of the 5 dose groups of 4, 10, 20, 40, and 60 mg were 673.
In terms of immunogenicity results, 6 samples from a total of 3 subjects tested positive for ADA (indicating that a certain biological drug was used in the human body to produce drug-resistant antibodies), of which 2 cases were in the experimental drug group, and none of them were immunized.
It is reported that the new coronavirus neutralizing antibody is a therapeutic antibody.
Related paper information: https://doi.
https://doi.
org/10.
1080/22221751.
2021.
1960900
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