ArkBio Completes Dosing of First Cohort in Australian Phase I Trial of Antiviral Drug-Fc Conjugate AK0406
Shanghai Ark Biopharmaceutical Co., Ltd. (ArkBio) announced on April 9, 2026, that the first cohort of healthy volunteers has been dosed in a Phase I clinical trial of AK0406 in Australia, following HREC approval.
AK0406 is a novel long-acting antiviral drug-Fc conjugate (ADFC) for influenza infection, combining a small-molecule antiviral with antibody Fc domain for broad-spectrum activity against influenza A and B, extended half-life, and immune clearance.
The trial is a single-center, randomized, double-blind, placebo-controlled study assessing safety, tolerability, and pharmacokinetics (PK) in healthy adults; data will guide dose selection for future trials.
This marks the first-in-human (FIH) evaluation of AK0406, a next-generation ADFC designed for prophylaxis and treatment of influenza.
Preclinical data demonstrate high-potency, broad-spectrum activity, maintained immune function, and prolonged exposure compared to first-generation ADFCs.