NCT05274516

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

Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of HRS-2261, the Effects of Food on the Pharmacokinetics of HRS-2261, and the Effects of HRS-2261 on CYP3A4 Metabolic Enzymes in Healthy Subjects After Single and Multiple Oral Administration

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Cough

Interventions

Type	Name	Description
DRUG	HRS-2261 tablet、placebo	HRS-2261 oral tablet, oral, single dose. Matching placebo to HRS-2261, oral, single dose.
DRUG	HRS-2261 tablet、placebo	HRS-2261 oral tablet, oral, BID. Matching placebo to HRS-2261, oral, BID.

Timeline

• Start date: 2022-03-28
• Primary completion: 2022-10-25
• Completion: 2022-10-25
• First posted: 2022-03-10
• Last updated: 2023-04-05

Locations

1 site across 1 country: China