Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects

Phase 1 Unknown 96 enrolled Shandong Suncadia Medicine Co., Ltd.

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.

Timeline

Start: 2023-02-02
Primary completion: 2023-12
Completion: 2023-12

Publications

Shen Q, Li L, Qian W, Dong X, Bao M, Huang R, Li N, Ye Z, Cheng G, Wang Q, Shen K, Luo Z. 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. Expert Opin Investig Drugs. 2024 Oct;33(10):1083-1093. doi: 10.1080/13543784.2024.2393867. Epub 2024 Aug 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HRS-1780	Small molecule	5 mg	Oral
Subject	HRS-1780	Small molecule	10 mg	Oral
Subject	HRS-1780	Small molecule	20 mg	Oral
Subject	HRS-1780	Small molecule	40 mg	Oral
Subject	HRS-1780	Small molecule	60 mg	Oral
Subject	HRS-1780	Small molecule	80 mg	Oral

Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects

Summary

Timeline

Publications

Drugs

Indications