The first subject from the Shanghai-based Huashan Hospital of Fudan University on Sunday morning received an injection of JS016 — a recombinant, fully human, monoclonal neutralizing antibody against COVID-19.
It is allegedly the world’s first clinical trial for the antibody on a healthy human participant after completing testing on non-human primates, according to the municipal science and technology commission of Shanghai.
The antibody, co-developed by biopharmaceutical company Junshi Biosciences, the Institute of Microbiology under the Chinese Academy of Sciences and others, entered the phase-1 clinical trial after approval by the National Medical Products Administration.
The randomized, double-blinded, placebo-controlled trial aims to evaluate the tolerability, safety, pharmacokinetic characteristics, and immunogenicity of JS016 among the Chinese population, to provide a basis for subsequent clinical studies of the antibody.
After being injected into the human body, JS016 can effectively block the binding of viruses to the host-cell surface receptor ACE2. This is because it is specific to the SARS-CoV-2 surface spike protein receptor-binding domain, according to Feng Hui, chief operating officer of Junshi Biosciences.
The trial was led by Zhang Jing, deputy director of the Institute of Antibiotics with the hospital, and Zhang Wenhong, head of the hospital’s Center for Infectious Disease.
Neutralizing antibody therapy is expected to be the first treatment option in fighting COVID-19, said Zhang Wenhong, noting that the antibody can accurately target the coronavirus and inhibit virus replication.