Chinese biopharmaceutical company Shanghai Ark Biopharmaceutical Co Ltd. (ArkBio) announced on Thursday that the first cohort of healthy volunteers has been dosed in a phase I clinical trial of AK0406, a novel long-acting antiviral drug-Fc conjugate (ADFC) drug for influenza infection, following approval by the Human Research Ethics Committee (HREC) in Australia.

ArkBio said that this milestone marks the first-in-human (FIH) evaluation of AK0406, and an important step in the global clinical development of its influenza pipeline.

AK0406 is a next-generation, long-acting ADFC candidate discovered and developed by ArkBio. By conjugating a potent small-molecule antiviral to the antibody Fc domain, AK0406 is designed to combine the direct antiviral effect of the payload with Fc-mediated immune clearance and an extended half-life. According to the company, preclinical data show that AK0406 exerts broad-spectrum, high-potency activity against both influenza A and B viruses, maintains immune effector function, and provides prolonged exposure. Compared with first-generation ADFC molecules, AK0406 is engineered to offer an optimised profile for both prophylaxis and treatment of influenza infection.

The phase I trial is a single-centre, randomised, double-blind, placebo-controlled study designed to assess the safety, tolerability, and pharmacokinetic profile of AK0406 in healthy adult participants in Australia. Data from the FIH study will inform subsequent dose selection and future proof-of-concept trials in populations at risk for influenza infection.