[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of LN016 sustained-release gel in patients undergoing unilateral open inguinal hernia repair
主要研究目的:
评价在单侧开放性腹股沟疝修补术参与者中灌注 LN016 缓释凝胶的安全性和耐受性。
次要研究目的:
评价在单侧开放性腹股沟疝修补术参与者中灌注LN016 缓释凝胶的药代动力学特征;
初步评价在单侧开放性腹股沟疝修补术参与者中灌注LN016 缓释凝胶的有效性。
探索性研究目的:
评价在单侧开放性腹股沟疝修补术参与者中LN016 缓释凝胶的新辅料(EN001)的血浆和尿液中代谢物的药代力学特征。
[Translation] Primary study objectives:
To evaluate the safety and tolerability of LN016 extended-release gel infusion in participants with unilateral open inguinal hernia repair.
Secondary study objectives:
To evaluate the pharmacokinetic characteristics of LN016 extended-release gel infusion in participants with unilateral open inguinal hernia repair;
To preliminarily evaluate the effectiveness of LN016 extended-release gel infusion in participants with unilateral open inguinal hernia repair.
Exploratory study objectives:
To evaluate the pharmacokinetic characteristics of metabolites of the new excipient (EN001) of LN016 extended-release gel in plasma and urine in participants with unilateral open inguinal hernia repair.