Phase 1 Study to Assess Safety and Effects of KN069 Injection in Chinese Men Aged 18 to 55 With Overweight or Obesity

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to study KN069 in Chinese male participants who are overweight or obese. This first-in-human, double-blind, placebo-controlled study aims to assess the safety, tolerability, how the drug moves through and acts in the body, and the immune response to KN069. The study focuses on men aged 18 to 55 with a body mass index between 24.0 and less than 35 kgm2, who meet specific health criteria related to blood sugar and overall health. Participants will be randomly assigned to one of several groups to receive a single subcutaneous injection of KN069 at doses ranging from 12mg to 240mg or a placebo. The study includes close monitoring after administration to evaluate the bodys reaction to the drug. The trial is designed to collect information on how KN069 is processed in the body and its potential effects on weight and waist size over time. During the study, participants will be monitored for up to 42 days with regular assessments for any side effects, blood tests to measure drug levels, and evaluations of weight, waist circumference, and body mass index changes. Researchers will also test for the presence of antibodies against KN069 to assess immune response. Participants must follow study procedures and restrictions while attending scheduled visits for medical exams and laboratory tests.

A Study to Evaluate Features of KN069 in Participants With Obesity or Overweight