[Translation] Single-center, randomized, double-blind, placebo-controlled, single-administration dose-escalating safety, tolerability and pharmacokinetics phase Ia clinical trial of NVS451 fusion protein for injection in healthy subjects
主要目的:评价注射用NVS451融合蛋白在健康受试者中单次皮下注射给药的安全性及耐受性;
次要目的:评价注射用NVS451融合蛋白在健康受试者中单次皮下注射给药的药代动力学(PK)特征;评价注射用NVS451融合蛋白在健康受试者中单次皮下注射给药的免疫原性;
探索性目的:探索注射用NVS451融合蛋白在健康受试者中单次皮下注射给药的生物标志物。
[Translation] Main purpose: To evaluate the safety and tolerability of a single subcutaneous injection of NVS451 fusion protein for injection in healthy subjects;
Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of NVS451 fusion protein for injection administered by single subcutaneous injection in healthy subjects; to evaluate the NVS451 fusion protein for injection administered by single subcutaneous injection in healthy subjects immunogenicity;
Exploratory purpose: To explore the biomarkers of NVS451 fusion protein for injection in healthy subjects administered with a single subcutaneous injection.