"A Single and Repeated Dose Escalation, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics and Preliminary Pharmacodynamics of RBD1016 in Subjects With Chronic Hepatitis B Virus (HBV) Infection“, has been Completed in Hong Kong, China .

RBD1016 is a GalNAc-siRNA being developed for treatment of hepatitis B. RBD1016 covers patient population with hepatitis B virus genotypes A-E and I, which represent the vast majority of hepatitis B patients in Europe, the United States and Asia. It has shown a highly efficient long-acting effect of reducing the HBsAg in serum and liver tissues in non-clinical studies. After a single treatment, inhibition of HBsAg lasted nearly 6 months. RBD1016 is the only anti-hepatitis B siRNA drug globally that demonstrated serological conversion in animal models, indicative of its BIC potential. RBD1016 has demonstrated well tolerated safety profile and pharmacokinetic characteristics expected for GalNAc-siRNA in clinical studies. Pharmacodynamic data on hepatitis B patients indicate that RBD1016 exhibits a relatively consistent and long-lasting inhibitory effect on HBsAg, HBV DNA, HBV RNA, and HBcrAg.