A Randomized, Double-blind, Placebo-controlled Phase II/III Trial Evaluating the Efficacy and Safety of Sufenidone (SC1011) Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)

The goal of this clinical trial is to evaluate the efficacy and safety of Sufenidone (SC1011) in patients with IPF, and to provide a new safe and effective treatment option for patients with IPF. Participants will complete the study including screening period, treating period, and follow-up period. Investigators will compare the annual rate of decline in FVC to see if it is an optional new drug. The participants have lung function tests at study visits. The results of the lung function tests are compared between the SC1011 groups and the placebo group. The doctors also regularly check the general health of the participants.

Start Date06 Jun 2023

Sponsor / Collaborator

Guangzhou Jiayue Pharmaceutical Technology Co., Ltd.

NCT06135363 / CompletedPhase 1

A Single-center, Open Label Study to Evaluate the Safety，Tolerability and Pharmacokinetics of Multiple Administration of Sufenidone (SC1011) Tablets in Healthy Adult Volunteers

The goal of this clinical trial is to learn about the safety, tolerability and pharmacokinetic profiles of SC1011 in healthy conditions. The main questions it aims to answer are: Safety and tolerability profiles in healthy subjects and pharmacokinetic profiles in healthy subjects. Participants will complete the study including screening period, dosing period, and observation period. Investigators will compare the inhibitory activity of SC1011 tablets with pirfenidone capsules against the same biomarkers(e.g. blood TNFα) to see if they are different between the two drugs.

Start Date11 Aug 2022

Sponsor / Collaborator

Guangzhou Jiayue Pharmaceutical Technology Co., Ltd.

CTR20221872 / RecruitingPhase 1

单中心、开放研究以评估舒非尼酮片在健康成人志愿者中多次给药的安全耐受性以及药代动力学特征

[Translation] A single-center, open-label study to evaluate the safety, tolerability and pharmacokinetic characteristics of sufenidone tablets after repeated dosing in healthy adult volunteers

评估舒非尼酮片在健康成人志愿者中多次给药的安全耐受性以及药代动力学特征

[Translation]

To evaluate the safety, tolerability and pharmacokinetic characteristics of sufenidone tablets after repeated administration in healthy adult volunteers

Start Date01 Aug 2022

Sponsor / Collaborator

Shijiazhuang Zhikang Hongren New Drug Development Co., Ltd.

100 Clinical Results associated with Sufenidone

100 Translational Medicine associated with Sufenidone

100 Patents (Medical) associated with Sufenidone

Literatures (Medical) associated with Sufenidone

12 Apr 2023·Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseases

[Protective effect of anti-idiopathic pulmonary fibrosis drug Pirfenidone and Sufenidone (SC1011) on pulmonary injury induced by tuberculosis in a mouse tuberculosis model].

Article

Author: Zheng, L Y ; Chen, X Y ; Lu, Y ; Wang, N ; Zhang, W Y ; Qi, X T ; Fu, L

Objective: To evaluate the protective effect of anti-idiopathic pulmonary fibrosis (IPF) marketed drug Pirfenidone and its clinical drug Sufenidone (SC1011) against lung injury in a mouse tuberculosis model. Methods: C57BL/6 mouse model of tuberculosis was established. A total of 75 C57BL/6 mice were infected with 1×10⁷ CFU/ml H37Rv suspension by aerosol and randomly divided into untreated (n=9) group, isoniazid+rifampicin+pyrazinamide (HRZ) group (n=22), PFD+HRZ group (n=22), and SC1011+HRZ group (n=22). C57BL/6 mice were infected with H37Rv by aerosol for 6 weeks and then treated. Seven mice in each treatment group were weighed, sacrificed, dissected and observed for lung and spleen lesions at 4 and 8 weeks of treatment. HE staining and Masson staining were used to assess degree of lung injury and fibrosis, respectively. ELISA was used to assess the IFN-γ/TNF-α content in the serum of mice in each treatment group after 4 weeks of treatment. Hydroxyproline (HYP) content in lung tissue was measured by alkaline hydrolysis; meanwhile, CFU counts were used to assess the bacterial load in the lung and spleen of mice in each treatment group and the recurrence of spleen and lung tissue after 12 weeks of drug withdrawal. Results: At 8 weeks, the HYP content in the lung tissue was (630±58), (635±17), and (840±70) μg/mg in the PFD+HRZ, SC1011+HRZ, and HRZ treatment group, respectively (P<0.05).At 8 weeks, the proportion of Masson staining blue-stained area, that was, positive area, in lung tissue was 16.65%±1.82%, 10.01%±2.16%, and 21.36%±3.21%, respectively (F=27.11, P<0.001).The lung injury scores by HE staining at 8 weeks were (5.00±0.50), (5.00±0.47), and (6.89±0.99) points, respectively (F=19.81, P<0.001).The results of 4-week ELISA showed that the levels of TNF-α and IFN-γ in the serum of the SC1011+HRZ-treated group were lower than those of the HRZ-treated group (all P<0.05).The degree of lung injury and fibrosis in PFD+HRZ and SC1011+HRZ treatment groups were lower than those in HRZ treatment group (all P<0.001). The number of viable bacteria in the lung tissue of mice treated with PFD+HRZ, SC1011+HRZ, and HRZ for 4 weeks was lower than that of mice untreated [(1.82±0.10), (1.91±0.05), (1.79±0.17) vs. (5.27±0.07) lg(CFU+1)/ml, all P<0.05)]. And the aseptic transformation of the spleen of mice was achieved in each treatment group at 8 weeks of administration. After 12 weeks of drug withdrawal, the recurrence of lung infection in the SC1011+HRZ treatment group was 3/7 lower than 5/7 in the HRZ treatment group (P>0.05); the recurrence of spleen infection in the SC1011+HRZ treatment group was 1/7 lower than 5/7 in the HRZ treatment group (P>0.05).Pulmonary infection recurred more frequently in PFD+HRZ 6/7 versus HRZ 5/7 (P>0.05). Conclusions: PFD/SC1011, when combined with HRZ, reduced lung injury and reduced secondary fibrosis in pulmonary tuberculosis in C57BL/6 mice. SC1011 combined with HRZ has no significant short-term therapeutic effect on MTB, but may reduce its recurrence rate in long-term treatment, especially in reducing the recurrence rate of mouse spleen.

100 Deals associated with Sufenidone

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Pulmonary Fibrosis	Phase 3	CN	Guangzhou Jiayue Pharmaceutical Technology Co., Ltd.	06 Jun 2023
Hypersensitivity	Phase 2	CN	Wuxi Zhikang Hongren New Drug Development Co., Ltd.	10 Jan 2019

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