Phase 1 Study Testing Safety and Effects of a Single Dose of HEC-151 Injection Compared to Insulin Degludec and Placebo in Healthy Adult Men

What this Trial Is About

Researchers are studying the safety, tolerability, and how the body absorbs and reacts to a single dose of HEC-151 Injection in healthy adult male volunteers. This Phase 1 clinical trial also evaluates immune response to the injection and compares it with insulin degludec and a placebo. The study is designed to understand the drugs effects in detail before further development. Participants receive one subcutaneous injection in the abdominal area on the morning of Day 1. Individuals are randomly assigned to receive either HEC-151 Injection, insulin degludec as an active comparator, or a placebo injection. The study is single-blind with placebo control and includes a positive control group. The treatment phase is followed by monitoring for safety and drug effects up to Day 36. During the trial, participants undergo regular assessments including monitoring for adverse events, vital signs like heart rate and blood pressure, and electrocardiogram parameters from Day 1 to Day 36. Blood samples are collected to measure drug concentration, metabolic effects, and immune response. Participants are observed closely for any side effects and overall tolerability throughout the study period, which lasts about five weeks.

Single-ascending Dose Study of HEC-151 Injection