[Translation] A multicenter, randomized, double-blind, placebo-controlled, dose-finding Phase Ib/IIa study to evaluate the safety, tolerability, and pharmacokinetic characteristics of TNM001 injection in healthy preterm and term infants in China
主要目的:评价在健康早产儿和足月儿中TNM001 注射液肌肉注射(IM)单次给药后的安全性和耐受性
次要目的:1)评价在健康早产儿和足月儿中TNM001 注射液肌肉注射单次给药的药代动力学(PK)特征
2)评价在健康早产儿和足月儿中TNM001 注射液IM 单次给药的PD 特征
3)评价在健康早产儿和足月儿中TNM001 注射液IM 单次给药的免疫原性
探索性目的:探索在健康早产儿和足月儿中接受TNM001 注射液后RSV引起的需医学干预的下呼吸道感染的发生率
[Translation] Primary objective: To evaluate the safety and tolerability of a single intramuscular (IM) dose of TNM001 injection in healthy preterm and term infants
Secondary objectives: 1) To evaluate the pharmacokinetic (PK) characteristics of a single intramuscular dose of TNM001 injection in healthy preterm and term infants
2) To evaluate the PD characteristics of a single IM dose of TNM001 injection in healthy preterm and term infants
3) To evaluate the immunogenicity of a single IM dose of TNM001 injection in healthy preterm and term infants
Exploratory objective: To explore the incidence of RSV-induced lower respiratory tract infections requiring medical intervention in healthy preterm and term infants after receiving TNM001 injection