NCT04554043

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

A Randomized, Double-blind, Dose-escalation, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of SHR7280 Tablets in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

GNRH antagonists can be used to treat sex hormone-dependent diseases, and SHR7280 is an oral GNRH antagonist. The purpose of this study is to observe the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of SHR7280 in healthy subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	SHR7280	treatment
DRUG	Placebo oral tablet	blank control

Timeline

• Start date: 2020-09-11
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2020-09-18
• Last updated: 2021-10-28

Locations

1 site across 1 country: China