The PK/PD Study of SHR7280 Tablets in Healthy Subjects.

Phase 1 Completed 118 enrolled Jiangsu HengRui Medicine Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in healthy subjects.

Timeline

Start: 2020-09-11
Primary completion: 2021-09-28
Completion: 2021-09-28

Publications

Li X, Sun F, Zhang X, Lin P, Shen K, Shen Y, Ma L, Cao Y, Wang C. Safety, pharmacokinetics, and pharmacodynamics of SHR7280, an oral gonadotropin-releasing hormone receptor antagonist, in healthy men: a randomized, double-blind, placebo-controlled phase 1 study. BMC Med. 2023 Apr 3;21(1):129. doi: 10.1186/s12916-023-02834-6.
Xu Y, Hu W, Li J, Jiang X, Shi P, Shen K, Shen Y, Ma L, Cao Y. Safety, pharmacokinetics, and pharmacodynamics of SHR7280, an oral gonadotropin-releasing hormone antagonist in healthy premenopausal women. Front Pharmacol. 2022 Nov 23;13:1027648. doi: 10.3389/fphar.2022.1027648. eCollection 2022.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SHR7280	Small molecule	100 mg	Oral
Subject	SHR7280	Small molecule	200 mg	Oral
Subject	SHR7280	Small molecule	300 mg	Oral
Subject	SHR7280	Small molecule	350 mg	Oral
Subject	SHR7280	Small molecule	400 mg	Oral
Subject	SHR7280	Small molecule	500 mg	Oral
Subject	SHR7280	Small molecule	600 mg	Oral
Subject	SHR7280	Small molecule	800 mg	Oral
Subject	SHR7280	Small molecule	1000 mg	Oral

Indications

No indication recorded.