[Translation] A randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of CPX101 in healthy participants after a single dose and in overweight or obese patients after multiple doses
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。
[Translation] SAD:
Primary objective To evaluate the safety and tolerability of a single dose of CPX101 in healthy participants.
Secondary objective To evaluate the pharmacokinetic (PK) characteristics of a single dose of CPX101 in healthy participants.
Exploratory objective To evaluate the immunogenicity of a single dose of CPX101 in healthy participants.
MAD:
Primary objective To evaluate the safety and tolerability of multiple doses of CPX101 in overweight and obese patients.
Secondary objectives To evaluate the preliminary efficacy of multiple doses of CPX101 in overweight and obese patients. To evaluate the PK characteristics of multiple doses of CPX101 in overweight and obese patients. To evaluate the immunogenicity of multiple doses of CPX101 in overweight and obese patients.