Zhengda Pharmaceutical (Guangzhou) Co., Ltd.

SAD： 主要目的 评估CPX101单次给药在健康参与者中的安全性和耐受性。 次要目的 评估CPX101单次给药在健康参与者中的药代动力学（PK）特征。 探索性目的 评价CPX101单次给药在健康参与者中的免疫原性。 MAD： 主要目的 评估CPX101多次给药在超重和肥胖患者中的安全性和耐受性。 次要目的 评估CPX101多次给药在超重和肥胖患者中的初步疗效。 评估CPX101多次给药在超重和肥胖患者中的PK特征。 评估CPX101多次给药在超重和肥胖患者中的免疫原性。

This randomized, double-blind, placebo-controlled Phase I clinical study was designed to evaluate the tolerability and safety, PK profile, immunogenicity of CPX101 in a single dose in healthy participants and multiple doses in overweight and obese patients, and to initially explore the efficacy of multiple doses in weight loss. The study was divided into two parts: single administration and dose escalation (SAD) and multiple administration and dose escalation (MAD).

The study is designed to evaluate the preliminary efficacy, safety, population PK profile, and immunogenicity of CPX101 in subjects with obesity or overweight with weight related comorbidities but without diabetes mellitus.