[Translation] Safety, tolerability, pharmacokinetics, immunogenicity, and dose investigation of a single intramuscular injection of XJ106-1 in healthy adult participants in China: a multicenter, randomized, double-blind, controlled, multi-cohort phase I/II clinical trial.
I期临床试验主要目的:
评价XJ106-1注射液单次肌肉注射在健康成年参与者中的安全性和耐受性。
I期临床试验次要目的:
研究单次肌肉注射XJ106-1注射液在健康成年参与者中的药代动力学(PK)特征;
评价单次肌肉注射XJ106-1注射液在健康成年参与者中预防破伤风的免疫原性;
评价单次肌肉注射XJ106-1注射液在健康成年参与者中预防破伤风的PK/PD特征。
II期临床试验主要目的:
比较XJ106-1注射液与破伤风人免疫球蛋白(HTIG)在健康人群中预防破伤风的有效性;
探索XJ106-1注射液单次肌肉注射预防破伤风的临床给药剂量。
II期临床试验次要目的:
评价单次肌肉注射XJ106-1注射液与吸附破伤风疫苗(TT)联合用药的安全性、耐受性、药代动力学(PK)和药效学(PD);
评价XJ106-1注射液单次肌肉注射在健康成年参与者中的安全性和耐受性;
研究单次肌肉注射XJ106-1注射液在健康成年参与者中的药代动力学(PK)特征;
评价单次肌肉注射XJ106-1注射液在健康成年参与者中预防破伤风的免疫原性。
[Translation] The primary objective of the Phase I clinical trial was to evaluate the safety and tolerability of a single intramuscular injection of XJ106-1 injection in healthy adult participants.
Secondary objectives of the Phase I clinical trial were to investigate the pharmacokinetic (PK) characteristics of a single intramuscular injection of XJ106-1 injection in healthy adult participants; to evaluate the immunogenicity of a single intramuscular injection of XJ106-1 injection for tetanus prevention in healthy adult participants; and to evaluate the PK/PD characteristics of a single intramuscular injection of XJ106-1 injection for tetanus prevention in healthy adult participants.
The primary objective of the Phase II clinical trial was to compare the efficacy of XJ106-1 injection with human tetanus immunoglobulin (HTIG) in preventing tetanus in healthy individuals; and to explore the clinical dosage of a single intramuscular injection of XJ106-1 injection for tetanus prevention.
Secondary objectives of the Phase II clinical trial: To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single intramuscular injection of XJ106-1 in combination with adsorbed tetanus vaccine (TT); To evaluate the safety and tolerability of a single intramuscular injection of XJ106-1 in healthy adult participants; To investigate the pharmacokinetic (PK) characteristics of a single intramuscular injection of XJ106-1 in healthy adult participants; To evaluate the immunogenicity of a single intramuscular injection of XJ106-1 in preventing tetanus in healthy adult participants.