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MAD0004J08, administered via intramuscular route, at 48, 100, and 400 mg is well-tolerated, and safe with minimal side effects.
A study revealed that a single intramuscular administration of MAD0004J08 (Fc engineered anti-SARS-CoV-2 monoclonal antibody) is safe, has good tolerability, rapidly distributes systemically, and is efficacious to neutralize various SARS-CoV-2 variants of concern (delta, alpha, gamma, beta). Simone Lanini et al. reported the findings of the initial 30 days of an ongoing phase 1 trial to explore pharmacokinetics, coronavirus neutralization titers, and safety of monoclonal antibody in 30 healthy volunteers.
The proportion of severe side effects was the primary outcome while pharmacokinetic and serum neutralization titers were the secondary outcomes ascertained. A single dose of MAD0004J08 administered intramuscularly was safe and well-tolerated. It led to rapid serum distribution and was capable of efficiently neutralizing major SARS-CoV-2 variants of concern.
Furthermore, it led to extremely elevated serum neutralization titers that were 5–76-fold greater in comparison with BNT162b2 mRNA vaccinees and COVID-19 convalescent donors. Hence, MAD0004J08 can be an important advancement in the preventive treatment and clinical supervision of SARS-CoV-2 infection.
Nature Communications
Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection
Simone Lanini et al.
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