China-based global biotech company Shanghai Ark Biopharmaceutical Co Ltd (ArkBio) announced on Wednesday the start of a Phase II clinical study of AK0610, a fully human monoclonal antibody designed to prevent respiratory syncytial virus (RSV) infection.

The multicentre, randomised, double-blind, placebo-controlled, dose-escalation phase II study is intended to evaluate the safety, tolerability, and pharmacokinetics of AK0610 Injection in healthy infants in China. It will be carried out at five centres nationwide, jointly headed by Professor Xin Ni of Beijing Children's Hospital, Capital Medical University, and Professor Hanmin Liu of West China Second Hospital, Sichuan University.

A monoclonal antibody targeting the pre-fusion F protein of RSV, AK0610 was isolated from a convalescent infant and subsequently engineered to improve durability. The company says that preclinical data showcased strong antiviral activity with an excellent safety profile. During the completed phase I trial in healthy adults, the product was safe, well-tolerated, and exhibited favourable pharmacokinetic properties.