[Translation] A double-blind, single-dose, dose-escalating, placebo-controlled, combined open-label, positive-controlled, parallel trial to evaluate the tolerability and safety of a single subcutaneous injection of increasing doses of GB08 injection in healthy adult subjects.
主要目的:1、在健康成年受试者中评价GB08注射液单剂量给药的耐受性和安全性。次要目的:1、在健康成年受试者中评价GB08注射液单剂量给药的药代动力学(PK)特征。2、在健康成年受试者中评价GB08注射液单剂量给药的药效动力学(PD)特征。3、在健康成年受试者中评价GB08注射液单剂量给药的免疫原性。
[Translation] Primary objectives: 1. To evaluate the tolerability and safety of a single dose of GB08 injection in healthy adult subjects. Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of a single dose of GB08 injection in healthy adult subjects. 2. To evaluate the pharmacodynamic (PD) characteristics of a single dose of GB08 injection in healthy adult subjects. 3. To evaluate the immunogenicity of a single dose of GB08 injection in healthy adult subjects.