[Translation] A single-center, double-blind, placebo-controlled, dose-escalation Phase I clinical study to evaluate the safety and tolerability of a single subcutaneous dose of BPR-30221616 injection in healthy subjects
主要目的:
>评估BPR-30221616注射液在健康受试者中单次给药的安全性和耐受性。
次要目的:
>评估BPR-30221616注射液在健康受试者中单次给药的药代动力学(PK)特征。
>评估BPR-30221616注射液在健康受试者中单次给药的血清转甲状腺素蛋白(TTR)水平。
>评估BPR-30221616注射液在健康受试者中单次给药的免疫原性。
探索性目的:
>评估BPR-30221616注射液在健康受试者中单次给药的血清维生素A和视黄醇结合蛋白水平。
[Translation] Primary objectives:
> To evaluate the safety and tolerability of a single dose of BPR-30221616 injection in healthy subjects.
Secondary objectives:
> To evaluate the pharmacokinetic (PK) characteristics of a single dose of BPR-30221616 injection in healthy subjects.
> To evaluate the serum transthyretin (TTR) level of a single dose of BPR-30221616 injection in healthy subjects.
> To evaluate the immunogenicity of a single dose of BPR-30221616 injection in healthy subjects.
Exploratory objectives:
> To evaluate the serum vitamin A and retinol binding protein levels of a single dose of BPR-30221616 injection in healthy subjects.