[Translation] A multicentre, randomized, double-blind, placebo-controlled, dose-finding trial evaluating the safety, tolerability, pharmacokinetics and preliminary efficacy of RB0026 injection in Chinese healthy preterm and full-term infants Ib/ Phase II trial
Ib期:
主要目的:
1.评价单次肌肉注射RB0026注射液的安全性和耐受性。
次要目的:
1.评价单次肌肉注射RB0026注射液的药代动力学PK特征;
2.评价单次肌肉注射RB0026注射液的药效动力学PD特征;
3.评价单次肌肉注射RB0026注射液的免疫原性。
II期:
主要目的:
1.在正在进入期第一个RSV流行季的婴儿人群中,评价RB0026注射液给药后150天内降低RSV引起的需医学干预的LRTI发生率。
次要目的:
1.评价RB0026注射液给药后150天内降低RSV所致住院发生率;
2.评价单次肌肉注射RB0026注射液后的安全性和耐受性;
3.评价单次肌肉注射RB0026注射液后的PK特征;
4.评价单次肌肉注射RB0026注射液后的PD特征;
5.评价单次肌肉注射RB0026注射液后的免疫原性。
探索性目的:
1.通过基因型和表型分析来描述对RB0026注射液的耐药特征;
评价给药后151-360天内RB0026注射液降低RSV引起的需医学干预的LRTI发生率。
[Translation] Phase Ib:
main purpose:
1. To evaluate the safety and tolerability of a single intramuscular injection of RB0026 injection.
Secondary purpose:
1. Evaluate the pharmacokinetic PK characteristics of a single intramuscular injection of RB0026 injection;
2. Evaluate the pharmacodynamic PD characteristics of a single intramuscular injection of RB0026 injection;
3. To evaluate the immunogenicity of a single intramuscular injection of RB0026 injection.
Phase II:
main purpose:
1. In the infant population entering the first RSV epidemic season, evaluate the reduction of the incidence of LRTI caused by RSV requiring medical intervention within 150 days after administration of RB0026 injection.
Secondary purpose:
1. To evaluate the reduction in the incidence of hospitalization caused by RSV within 150 days after administration of RB0026 injection;
2. To evaluate the safety and tolerability of a single intramuscular injection of RB0026 injection;
3. Evaluate the PK characteristics after a single intramuscular injection of RB0026 injection;
4. Evaluate the PD characteristics after a single intramuscular injection of RB0026 injection;
5. To evaluate the immunogenicity after a single intramuscular injection of RB0026 injection.
Exploratory purpose:
1. Describe the characteristics of drug resistance to RB0026 injection through genotype and phenotype analysis;
To evaluate the reduction of the incidence of RSV-induced LRTI requiring medical intervention by RB0026 injection within 151-360 days after administration.