Hua Medicine Doses First Patient in US Phase Ib Trial of HMS1005 for Type 2 Diabetes
Hua Medicine announced that the first patient has been successfully dosed in the U.S.-based multiple-ascending dose (MAD) Phase Ib clinical trial of its second generation glucokinase activator (GKA), HMS1005, for participants with Type 2 diabetes mellitus (T2D). The randomized, double-blinded, placebo-controlled study will investigate the safety, tolerability, pharmacokinetic profile, and pharmacodynamic effects of multiple ascending doses of HMS1005. The trial will evaluate pharmacodynamic biomarkers such as glucose, insulin, C-peptide, GLP-1, and glucagon under fasting and fed conditions, and monitor glucose fluctuation using continuous glucose monitoring (CGM). HMS1005 is described as a new molecular entity with improved physical-chemical properties, designed as an extended-release formulation for once-daily administration. The company previously completed a single-ascending dose study of HMS1005 in the United States. Upon successful completion of the MAD Phase Ib study, Hua Medicine intends to seek partners for global development of HMS1005. The company cautions that there is no guarantee of successful development or commercialization of the product.
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