[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalating Phase Ib clinical study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of multiple doses of insulin secretion-promoting peptide fusion protein (HB1085) for injection in healthy subjects
主要目的:
评价HB1085在健康受试者中连续多次给药的安全性、耐受性;
评价不同剂量的HB1085多次给药在健康受试者中的药代动力学特征。
次要目的:
初步评价多次给药不同剂量HB1085在健康受试者中的药效动力学特征;
为后续HB1085的临床研究提供剂量选择依据;
评价不同剂量下HB1085多次给药在健康受试者中的免疫原性。
[Translation] Main purpose:
Evaluate the safety and tolerability of HB1085 after multiple continuous administration in healthy subjects;
Evaluate the pharmacokinetic characteristics of different doses of HB1085 after multiple administration in healthy subjects.
Secondary purpose:
Preliminary evaluation of the pharmacodynamic characteristics of different doses of HB1085 after multiple administration in healthy subjects;
Provide a basis for dose selection for subsequent clinical studies of HB1085;
Evaluate the immunogenicity of HB1085 after multiple administration in healthy subjects at different doses.