HUA MEDICINE-B (02552) announced that the first patient has been successfully dosed in the U.S. multiple ascending dose (MAD) Ib clinical trial for its second-generation glucokinase activator (GKA), HMS1005 (formerly HM-002-1005). This randomized, double-blind, placebo-controlled study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HMS1005 in subjects with type 2 diabetes (T2D).

The trial will further investigate the mechanism and efficacy of HMS1005 by assessing PD markers (including blood glucose, insulin, C-peptide, GLP-1, and glucagon) under fasting and fed conditions, as well as monitoring glucose fluctuations via continuous glucose monitoring (CGM). HMS1005 is a novel molecular entity with improved physicochemical properties, designed as a once-daily extended-release formulation to enhance patient convenience and prolong intestinal exposure, thereby improving GLP-1 secretion deficiency.

Previously, the company successfully completed and disclosed results from a single ascending dose study of HMS1005 in the U.S., confirming its feasibility for once-daily oral treatment in T2D and obese patients. Following the successful completion of the MAD Ib trial, HUA MEDICINE-B plans to seek partnerships for the global development of HMS1005.