预约演示
更新于：2026-07-15
HRS-1780
更新于：2026-07-15
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
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关联
8
项与 HRS-1780 相关的临床试验NCT07557407
An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]HRS-1780 After a Single Oral Dose to Healthy Male Subjects
NCT07470983
A Multicenter, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS-1780 in Participants With Primary Aldosteronism
NCT07419828
A Multicenter, Randomized, Double-blind, Placebo- Controlled Phase III Study Evaluating the Efficacy and Safety of HRS-1780 in Adult Participants With Chronic Kidney Disease
100 项与 HRS-1780 相关的临床结果
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100 项与 HRS-1780 相关的转化医学
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100 项与 HRS-1780 相关的专利（医药）
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3
项与 HRS-1780 相关的文献（医药）2024-10-02EXPERT OPINION ON INVESTIGATIONAL DRUGS
A four-in-one first-in-human study to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and concentration-QTc relationship of HRS-1780, a selective non-steroidal mineralocorticoid receptor antagonist, in healthy men
Article
作者: Li, Na ; Qian, Weilin ; Li, Lingzhi ; Shen, Qi ; Luo, Zhu ; Wang, Quanren ; Dong, Xue ; Shen, Kai ; Ye, Zi ; Huang, Rong ; Cheng, Gang ; Bao, Manchen
BACKGROUND:
This first-in-human study evaluated HRS-1780, an oral selective non-steroidal mineralocorticoid receptor antagonist, in healthy men.
RESEARCH DESIGN AND METHODS:
In single ascending dose (SAD) part, 10 participants for each dose cohort (5, 10, 20, 40, 60, and 80 mg) were randomized (8:2) to HRS-1780 or placebo. In multiple ascending dose part, 12 participants for each dose (10, 20, and 40 mg) were randomized (9:3) to HRS-1780 or placebo once daily for 7 days. The primary endpoint was safety and tolerability.
RESULTS:
HRS-1780 was well tolerated with all adverse events being mild. In the steady state, the median time to maximum concentration (Tmax) was 0.750 h and mean half-life was 1.76-1.96 h. High-fat/high-calorie meal prolonged Tmax but did not affect exposure. Multiple dosing of HRS-1780 at 40 mg showed a decreasing trend in systolic blood pressure compared with placebo. Changes in plasma aldosterone and norepinephrine with HRS-1780 were higher compared to placebo. Upper bounds of two-sided 90% confidence interval of placebo-adjusted change-from-baseline QTcF were below 10 msec at the maximum concentration in SAD. The trial had limited sample size and short study duration.
CONCLUSIONS:
HRS-1780 had favorable safety and pharmacokinetic profiles and did not cause clinically meaningful QTcF prolongation.
TRIAL REGISTRATION:
ClinicalTrials.gov (NCT05638126).
Drug Design Development and Therapy
Pharmacokinetics and Safety of HRS-1780 in Renal Impaired Subjects: A Multicenter, Non-Randomized, Open-Label Study
Article
作者: Zhu, Yijing ; Wang, Quanren ; Xie, Zhihong ; Luo, Yuanyuan ; Yong, Xiaolan ; Lan, Dongmei ; Du, Xiaolin ; Huang, Rong ; Li, Na ; Cheng, Gang ; Shen, Kai ; Fei, Yue ; Qi, Yang
Purpose:
HRS-1780 is a selective non-steroidal mineralocorticoid receptor antagonist developed for the treatment of chronic kidney disease. This study aimed to assess the pharmacokinetics (PK) and safety profiles of HRS-1780 in subjects with renal impairment.
Patients and Methods:
Eligible participants were enrolled in the healthy (glomerular filtration rate [GFR] of ≥90 mL/min), mild (GFR of 60-89 mL/min), and moderate renal impairment (GFR of 30-59 mL/min) groups with 9 subjects each and orally received 20 mg HRS-1780. Concentrations of HRS-1780 and its main metabolites were measured in plasma and urine. PK profiles between healthy and renal impairment subjects were compared using analysis of variance.
Results:
A total of 27 subjects completed the study. HRS-1780 was rapidly absorbed and eliminated, with Tmax of 0.50-0.52 hour and t1/2 of 2.06-2.56 hours. Exposure (AUC0-inf) to HRS-1780 was comparable between mildly and moderately renal impaired subjects, while higher, but not significantly than that in healthy subjects. Similar plasma protein binding among different renal function groups suggested a consistent effect of renal function on total and unbound HRS-1780. Renal clearance of HRS-1780 decreased with severity of renal impairment, but renal elimination of HRS-1780 was minimal. Exposure to SX2183-M3 was significantly increased in the moderate renal impairment subjects. Renal impairment did not appear to be associated with an increased risk of adverse events.
Conclusion:
HRS-1780 PK and safety profiles did not differ significantly between healthy and renal impairment subjects. This supports the drug dose regimen for renal impairment patients in clinical practice.
Drug Design Development and Therapy
Pharmacokinetics and Safety of HRS-1780 in Renal Impaired Subjects: A Multicenter, Non-Randomized, Open-Label Study [Corrigendum]
作者: Zhu, Yijing ; Wang, Quanren ; Xie, Zhihong ; Luo, Yuanyuan ; Yong, Xiaolan ; Du, Xiaolin ; Lan, Dongmei ; Huang, Rong ; Li, Na ; Cheng, Gang ; Shen, Kai ; Fei, Yue ; Qi, Yang
[This corrects the article DOI: 10.2147/DDDT.S500384.].
100 项与 HRS-1780 相关的药物交易
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研发状态
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 难治性高血压 | 临床3期 | 中国 | 2026-07-15 | |
| 慢性肾病 | 临床3期 | 中国 | 2026-03-13 | |
| 醛固酮增多症 | 临床2期 | 中国 | 2026-04-20 | |
| 2型糖尿病 | 临床1期 | 中国 | 2024-07-15 | |
| 心脏衰竭 | 临床申请批准 | 中国 | 2025-11-21 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 134 | 艱憲繭簾夢廠範選獵製(積鏇顧網蓋醖餘鏇願蓋) = 壓選齋積築餘鑰壓選鏇 衊簾鬱構淵築鹹鏇蓋壓 (遞顧獵餘襯鑰壓糧顧淵 ) | 积极 | 2025-11-06 | |||
艱憲繭簾夢廠範選獵製(積鏇顧網蓋醖餘鏇願蓋) = 製襯鹽鏇網憲壓窪壓淵 衊簾鬱構淵築鹹鏇蓋壓 (遞顧獵餘襯鑰壓糧顧淵 ) | |||||||
临床1期 | - | - | HRS-1780 5mg | 網築餘簾顧鬱膚壓衊齋(顧鏇壓艱蓋襯範網積鏇) = 醖窪鹹繭觸窪鏇遞構餘 網夢網壓齋襯鹽餘鬱遞 (遞鹹夢餘夢襯廠製簾壓 ) 更多 | 积极 | 2024-08-26 | |
HRS-1780 10mg | - |
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