[Translation] Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of single/multiple intravenous administration of GPN00068 injection in healthy subjects
主要目的:
1) 评估健康受试者单次静脉给药GPN00068注射液的安全性与耐受性;
2) 评估健康受试者单次静脉给药GPN00068注射液的药代动力学特征;
次要目的:
1) 健康受试者单次静脉给药GPN00068注射液后鉴定体内代谢物;
2) 初步评估中国健康受试者单次静脉给药GPN00068注射液尿药的累积排泄率。
[Translation] Primary objectives:
1) To evaluate the safety and tolerability of a single intravenous administration of GPN00068 injection in healthy subjects;
2) To evaluate the pharmacokinetic characteristics of a single intravenous administration of GPN00068 injection in healthy subjects;
Secondary objectives:
1) To identify metabolites in vivo after a single intravenous administration of GPN00068 injection in healthy subjects;
2) To preliminarily evaluate the cumulative excretion rate of GPN00068 injection in urine after a single intravenous administration in healthy Chinese subjects.