[Translation] A multicenter, randomized, double-blind, placebo-controlled phase II study on the efficacy, safety, and pharmacokinetics of RN-0001 intravenous injection in preventing acute kidney injury after extracorporeal circulation cardiac surgery

1）评估RN-0001在择期行体外循环心脏手术兼具发生术后AKI高风险的患者中，多次静脉给药预防AKI发生的有效性和安全性； 2）评估RN-0001在择期行体外循环心脏手术兼具发生术后AKI高风险的患者中，多次静脉给药的药代动力学特征。

[Translation]

1) To evaluate the efficacy and safety of multiple intravenous administration of RN-0001 in preventing AKI in patients who are scheduled to undergo extracorporeal circulation heart surgery and are at high risk of postoperative AKI; 2) To evaluate the pharmacokinetic characteristics of multiple intravenous administration of RN-0001 in patients who are scheduled to undergo extracorporeal circulation heart surgery and are at high risk of postoperative AKI.

Start Date-

Sponsor / Collaborator

Rui Nuo Medical Technology (Shanghai) Co Ltd

CTR20210228

/ CompletedPhase 1

RN-0001 在中国健康受试者中单次和多次静脉给药的安全性、耐受性及药代动力学研究

[Translation] Safety, tolerability and pharmacokinetics of RN-0001 after single and multiple intravenous administration in healthy Chinese subjects

(1) 评估RN-0001 在中国健康受试者中单次和多次静脉给药的安全性和耐受性。 (2) 评估RN-0001 在中国健康受试者中单次和多次静脉给药的药代动力学特征。

[Translation]

(1) To evaluate the safety and tolerability of RN-0001 after single and multiple intravenous administration in healthy Chinese subjects. (2) To evaluate the pharmacokinetic characteristics of RN-0001 after single and multiple intravenous administration in healthy Chinese subjects.

Start Date08 Mar 2021

Sponsor / Collaborator

Rui Nuo Medical Technology (Shanghai) Co Ltd

100 Clinical Results associated with RN-0001

100 Translational Medicine associated with RN-0001

100 Patents (Medical) associated with RN-0001

100 Deals associated with RN-0001

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Kidney Injury	Phase 2	China	Rui Nuo Medical Technology (Shanghai) Co Ltd	13 Feb 2023
Pancreatitis	IND Approval	China	Rui Nuo Medical Technology (Shanghai) Co Ltd	30 Jan 2022
Hepatitis B	Preclinical	China	Rui Nuo Medical Technology (Shanghai) Co Ltd	30 Jan 2022
Hepatitis D	Preclinical	China	Rui Nuo Medical Technology (Shanghai) Co Ltd	30 Jan 2022
Inflammation	Preclinical	China	Rui Nuo Medical Technology (Shanghai) Co Ltd	30 Jan 2022
Nerve Degeneration	Preclinical	China	Rui Nuo Medical Technology (Shanghai) Co Ltd	30 Jan 2022

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