Phase 1 Study to Assess Safety, Tolerability, and Drug Behavior of TQF3250 Capsules in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating TQF3250 capsules, a biased GLP-1 receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., in healthy adult subjects with hyperglycemia. This Phase 1a clinical trial aims to study the safety, tolerability, and pharmacokinetic characteristics of TQF3250 after single administration and escalating doses. The capsule selectively activates certain pathways of the GLP-1 receptor to potentially offer better effects with fewer side effects. Participants will be randomly assigned to receive either a TQF3250 capsule or placebo. The treatment involves oral administration in two cycles of 10 days each. One group will take the capsule while fasting once, and the other group will take it once per cycle after eating to assess the foods influence. The study uses quadruple masking to maintain blinding. During the study, participants will be monitored closely for adverse events, vital signs, electrocardiograms, and laboratory test results up to 20 days. Researchers will assess changes in body temperature, heart rate, respiratory rate, blood pressure, and blood oxygen levels within 24 hours of dosing. Pharmacokinetic measures such as peak drug concentration and drug exposure over time will also be evaluated. Participants are expected to comply with study procedures and dietary requirements throughout the trial.

A Clinical Trial Evaluating TQF3250 Capsules in Healthy Adult Subjects