Phase 1 Study to Assess Safety and Effects of HEC-007 Injection Given as Single Dose in Healthy Adults and Multiple Doses in Overweight or Obese Adults

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection in both healthy adults and overweight or obese subjects. This Phase 1 clinical trial uses a randomized, double-blind, placebo-controlled, dose-escalation design to study the effects of a single dose in healthy subjects and multiple doses in overweight or obese participants. The trial is conducted at a single center and aims to better understand how the drug behaves and is tolerated in these different populations. The study is divided into two parts Part A involves a single ascending dose SAD study with 54 healthy Chinese adults receiving either HEC-007 Injection or placebo administered once. Part B is a multiple ascending dose MAD study with 72 overweight or obese Chinese subjects receiving multiple doses of HEC-007 Injection or placebo. The dosing schedules vary between the single and multiple dose administrations to evaluate different aspects of the drugs pharmacological profile. Participants will be monitored from screening through up to day 43 or day 113 post-dose depending on the study part. Assessments include vital signs, physical exams, laboratory tests, ECGs, imaging, and questionnaires about body weight, waist circumference, fasting plasma glucose, insulin levels, and blood lipids. Researchers will track adverse events, drug concentration over time, and changes from baseline in metabolic and anthropometric measures to evaluate safety and drug effects. The total participation time varies based on the study phase and dose escalation.

A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects