Phase 1 Study Evaluating Safety and Effects of HMS1005 in Adults with Type 2 Diabetes

What this Trial Is About

Researchers are evaluating the safety, how the body processes, and the effects of HMS1005 in adults with type 2 diabetes. This phase 1, randomized, double-blind, placebo-controlled study aims to understand how different doses of HMS1005 work and are tolerated by patients. The trial includes people with type 2 diabetes who meet specific health and treatment criteria. Participants will receive HMS1005 tablets or matching placebo in multiple ascending doses. The study includes several groups where six participants receive the active drug and two receive placebo at each dose level. The doses range from 123 mg to 492 mg, given as one or two tablets. The treatment and monitoring occur over about 19 days, including single-dose and steady-state phases. During the study, participants will undergo various evaluations including blood tests to measure glucose levels and drug concentration in plasma, physical exams, ECGs, vital signs, and laboratory tests. Researchers will track adverse events from enrollment through day 19 and measure pharmacokinetic parameters such as drug concentration over time. The overall participation time aligns with the dosing and monitoring schedule, ensuring safety and detailed assessment of the drugs effects.

A Phase 1, Multiple Ascending Dose Study to Evaluate HMS1005 in Participants With Type 2 Diabetes