[Translation] An exploratory phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of CXJM-66 injection in healthy subjects
主要目的:评价CXJM-66注射液在健康受试者中经局部浸润和神经阻滞给药后的安全性、耐受性及确定Ⅱ期推荐剂量(RP2D)。
次要目的:
评价CXJM-66注射液在健康受试者中经局部浸润和神经阻滞给药后的药代动力学特征。
探索性研究目的:
1)评价CXJM-66注射液在健康受试者中经局部浸润和神经阻滞给药后的药效动力学特征;
2)评价CXJM-66注射液在健康受试者中经神经阻滞给药后,血药浓度对QTc间期的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of CXJM-66 injection in healthy subjects after local infiltration and nerve blockade and to determine the recommended dose (RP2D) for Phase II.
Secondary objective: To evaluate the pharmacokinetic characteristics of CXJM-66 injection in healthy subjects after local infiltration and nerve blockade.
Exploratory study objectives:
1) To evaluate the pharmacodynamic characteristics of CXJM-66 injection in healthy subjects after local infiltration and nerve blockade;
2) To evaluate the effect of blood drug concentration on QTc interval after CXJM-66 injection was administered via nerve blockade in healthy subjects.