A Trial of HRS-2261 in Healthy Subjects After Single and Multiple Oral Administration

Phase 1 Completed 92 enrolled Guangdong Hengrui Pharmaceutical Co., Ltd

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a first-in-human study that will investigate the safety, tolerability and pharmacokinetics of single and multiple ascending doses of HRS-2261 using a double blind, placebo controlled, randomized study design. The influence of food on the pharmacokinetics of HRS-2261 and the effects of HRS-2261 on CYP3A4 metabolic enzymes will also be investigated.

Timeline

Start: 2022-03-28
Primary completion: 2022-10-25
Completion: 2022-10-25

Publications

Fan Y, Zhang X, Zhang Q, Zheng L, Zhou R, Sun C, Wang X, Song K, He Z, Wang H, Zhang Q, Hu W. Safety and Pharmacokinetics of HRS-2261, a P2X3 Receptor Antagonist, in Healthy Subjects: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Clin Pharmacokinet. 2024 Mar;63(3):293-302. doi: 10.1007/s40262-023-01330-7. Epub 2024 Jan 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HRS-2261	Unknown	25 mg	Oral
Subject	HRS-2261	Unknown	50 mg	Oral
Subject	HRS-2261	Unknown	100 mg	Oral
Subject	HRS-2261	Unknown	200 mg	Oral
Subject	HRS-2261	Unknown	400 mg	Oral
Subject	HRS-2261	Unknown	800 mg	Oral
Subject	HRS-2261	Unknown	1200 mg	Oral

Indications

No indication recorded.