[Translation] Study on drug concentration and penetration in lung epithelial lining fluid after intravenous infusion of ASK0912 in healthy Chinese subjects

主要目的：评价注射用ASK0912在健康受试者中多剂静脉输注给药后经支气管肺泡灌洗后肺上皮衬液和巨噬细胞浓度及穿透率。次要目的：评价注射用ASK0912在健康受试者中血浆药代动力学特征。评价注射用ASK0912在健康受试者中多剂静脉输注给药的安全性和耐受性。

[Translation]

Primary objective: To evaluate the concentration and penetration rate of ASK0912 for injection in lung epithelial lining fluid and macrophages after bronchoalveolar lavage after multiple doses of intravenous infusion in healthy subjects. Secondary objective: To evaluate the plasma pharmacokinetic characteristics of ASK0912 for injection in healthy subjects. To evaluate the safety and tolerability of multiple doses of intravenous infusion of ASK0912 for injection in healthy subjects.

Start Date24 Sep 2024

Sponsor / Collaborator

Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences

[+1]

CTR20222379 / CompletedPhase 1

随机、双盲、安慰剂对照评价注射用 ASK0912 在中国健康受试者中单剂和多剂静脉输注给药剂量递增的安全性、耐受性及药代动力学特征的Ⅰ期临床试验

[Translation] A randomized, double-blind, placebo-controlled Phase I clinical trial to evaluate the safety, tolerability and pharmacokinetic characteristics of single and multiple intravenous infusions of ASK0912 for injection in healthy Chinese subjects

主要目的：评价注射用ASK0912在健康受试者中单剂、多剂静脉输注给药的安全性和耐受性。次要目的：评价注射用ASK0912在健康受试者中单剂、多剂静脉输注给药后的药代动力学特征。探索性研究目的：探索性分析注射用ASK0912单剂和多剂给药后，早期肾损伤指标较基线的变化。探索性分析注射用ASK0912可能的代谢产物及代谢途径。探索性分析注射用ASK0912单剂给药后，ASK0912的血浆药物浓度与QTC间期之间的量效关系。

[Translation]

Primary objective: To evaluate the safety and tolerability of single-dose and multiple-dose intravenous infusion of ASK0912 for injection in healthy subjects. Secondary objective: To evaluate the pharmacokinetic characteristics of single-dose and multiple-dose intravenous infusion of ASK0912 for injection in healthy subjects. Purpose of exploratory study: To explore the changes of early renal injury indicators compared with baseline after single-dose and multiple-dose administration of ASK0912 for injection. To explore the possible metabolites and metabolic pathways of ASK0912 for injection. To explore the dose-effect relationship between plasma drug concentration of ASK0912 and QTC interval after single-dose administration of ASK0912 for injection.

Start Date02 Dec 2022

Sponsor / Collaborator

Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences

[+1]

100 Clinical Results associated with ASK-0912

100 Translational Medicine associated with ASK-0912

100 Patents (Medical) associated with ASK-0912

Literatures (Medical) associated with ASK-0912

01 Aug 2023·Biomedicine & Pharmacotherapy

Protective effect of the novel cyclic peptide ASK0912 on mice with sepsis induced by Acinetobacter baumannii

Article

Author: Hu, Xinxin ; Yang, Xinyi ; Pang, Pengbo ; Wang, Xiukun ; Wu, Huige ; Wang, Penghe ; Li, Guoqing ; Lu, Yun ; Nie, Tongying ; You, Xuefu ; Li, Congran ; Li, Xue ; Xie, Chunyang

BACKGROUNDSepsis has become a global health concern owing to its increasing incidence and high mortality rate. In the present study, we investigated a novel drug candidate ASK0912 on its protective effects in mice with Acinetobacter baumannii 20-1-induced sepsis, and studied the related mechanisms.MATERIAL AND METHODSTo analyze the protective effect of ASK0912 on septic mice, survival rates, body temperature, organ and blood bacterial loads, white blood cell and platelet counts, organ damage, and cytokine levels were determined.RESULTSASK0912 remarkably increased the survival rate of mice with sepsis induced by A. baumannii 20-1 at a low dose of 0.6 mg/kg. Rectal temperature measurements showed that ASK0912 treatment prevented the body temperature decrease of septic mice to some extent. Treatment with ASK0912 can notably reduce the organ and blood bacterial loads and alleviate platelet count reduction due to sepsis. ASK0912 attenuated organ damage, including reduced levels of total bile acids, urea, and creatinine, aggregation of inflammatory cells, and mitigation of structural changes in septic mice, as demonstrated by biochemical analysis and hematoxylin & eosin staining. Additionally, multiplex assay showed that abnormally increased cytokine levels (IL-1β, IL-3, IL-5, IL-6, IL-10, IL-13, MCP-1, RANTES, KC, MIP-1α, MIP-1β, and G-CSF) in septic mice decreased after ASK0912 treatment.CONCLUSIONSASK0912 can not only improve the survival rate, hypothermia, lower the bacterial loads in the organs and blood, but also alleviate the pathophysiological manifestations such as intravascular coagulation abnormalities, organ damages, and immune system disorder of sepsis mice induced by A. baumannii 20-1.

100 Deals associated with ASK-0912

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Indication	Highest Phase	Country/Location	Organization	Date
Gram-Negative Bacterial Infections	Phase 1	CN	Jiangsu Aosaikang Pharmaceutical Co. Ltd.	02 Dec 2022
Gram-Negative Bacterial Infections	Phase 1	CN	Institute of Pharmaceutical Biotechnology, Chinese Academy of Medical Sciences	02 Dec 2022

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