[Translation] An exploratory Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single intravenous dose of RFUS-250 for injection in healthy volunteers
主要目的:评价中国健康志愿者单次静脉给予注射用RFUS-250的安全性、耐受性。
次要目的:
1)评价中国健康志愿者单次静脉给予注射用RFUS-250后的药代动力学特征;
2)检测中国健康志愿者血液、尿液和粪便中的RFUS-250及其代谢产物,初步评估排泄途径。
探索性目的:
1)探索性评估中国健康志愿者单次静脉给予注射用RFUS-250后的镇痛药效;
2)探索性评估中国健康志愿者单次静脉给予注射用RFUS-250后原药及代谢产物(如需要)血药浓度对QTc间期的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of RFUS-250 for injection after a single intravenous administration to healthy Chinese volunteers.
Secondary objectives:
1) To evaluate the pharmacokinetic characteristics of RFUS-250 for injection after a single intravenous administration to healthy Chinese volunteers;
2) To detect RFUS-250 and its metabolites in the blood, urine and feces of healthy Chinese volunteers, and preliminarily evaluate the excretion pathway.
Exploratory objectives:
1) To explore the analgesic efficacy of RFUS-250 for injection after a single intravenous administration to healthy Chinese volunteers;
2) To explore the effect of the blood concentration of the original drug and metabolites (if necessary) on the QTc interval after a single intravenous administration of RFUS-250 for injection to healthy Chinese volunteers.