[Translation] Study 1: A randomized, double-blind, placebo-controlled, single-dose ascending phase I clinical trial of HZ010 in healthy subjects
Study 2: A randomized, double-blind, placebo-controlled, multiple-dose ascending phase I clinical trial of HZ010 in healthy subjects
主要目的:
1、通过健康受试者单次皮下注射浙江和泽医药科技股份有限公司研发的HZ010,考察HZ010的安全性和耐受性,为后续临床试验剂量选择提供参考依据;
2、通过健康受试者多次皮下注射浙江和泽医药科技股份有限公司研发的HZ010,考察HZ010的安全性和耐受性,为后续临床试验剂量选择提供参考依据。
次要目的:
考察HZ010在健康受试者体内单次给药和多次给药的药代动力学特征以及多次给药后药效学特征。
[Translation] Main purpose:
1. To investigate the safety and tolerability of HZ010 developed by Zhejiang Heze Pharmaceutical Technology Co., Ltd. by single subcutaneous injection in healthy subjects, and provide a reference for the dose selection of subsequent clinical trials;
2. To investigate the safety and tolerability of HZ010 developed by Zhejiang Heze Pharmaceutical Technology Co., Ltd. by multiple subcutaneous injection in healthy subjects, and provide a reference for the dose selection of subsequent clinical trials.
Secondary purpose:
To investigate the pharmacokinetic characteristics of HZ010 after single and multiple administrations in healthy subjects, and the pharmacodynamic characteristics after multiple administrations.