[Translation] A randomized, double-blind, placebo-controlled, parallel-group, single-dose, dose-escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, and absolute bioavailability of TNM009 injection in healthy adult subjects
本研究主要目的是评价在健康成人受试者中TNM009注射液(以下简称TNM009)单次皮下(SC)或静脉(IV)给药后的安全性和耐受性);次要目的是评价在健康成人受试者中TNM009单次SC或IV给药后的药代动力学(PK)特征;评价在健康成人受试者中TNM009单次SC给药的绝对生物利用度;评价在健康成人受试者中TNM009单次SC或IV给药后的免疫原性;探索性目的是评价健康成人受试者中TNM009单次SC或IV给药对神经生长因子水平的影响。
[Translation] The primary objective of this study is to evaluate the safety and tolerability of TNM009 injection (hereinafter referred to as TNM009) after a single subcutaneous (SC) or intravenous (IV) administration in healthy adult subjects; the secondary objective is to evaluate the pharmacokinetic (PK) characteristics of TNM009 after a single SC or IV administration in healthy adult subjects; to evaluate the absolute bioavailability of TNM009 after a single SC administration in healthy adult subjects; to evaluate the immunogenicity of TNM009 after a single SC or IV administration in healthy adult subjects; the exploratory objective is to evaluate the effect of a single SC or IV administration of TNM009 on the level of nerve growth factor in healthy adult subjects.