NCT06920836

QR052107B Tablets in Patients With Subacute Cough of Phase Ⅱ Study

A Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of QR052107B Tablets in Patients With Subacute Cough

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Wuhan Createrna Science and Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to Evaluate the Efficacy and Safety of QR052107B 100mg， QR052107B 400mg in Patients with Subacute Cough.

Detailed description

This study adopted a multicenter, randomized, parallel-group, double-blind and placebo-controlled design, and it was planned to enroll 270 patients with subacute cough following respiratory tract infection. After a screening period of 1-4 days, eligible subjects were randomized to the QR052107B 100 mg QD group, QR052107B 400 mg QD group and placebo group at a ratio of 1:1:1. The efficacy of QR052107B Tablets in the treatment of subacute cough was evaluated after 9 consecutive days of dosing. This study is divided into 3 stages: screening period, administration and observation period, and safety follow-up period.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	QR052107B 100 mg	QR052107B 100 mg QD
DRUG	QR052107B 400 mg	QR052107B 400 mg QD
DRUG	Placebo	placebo QD

Timeline

• Start date: 2023-06-21
• Primary completion: 2023-11-22
• Completion: 2023-12-25
• First posted: 2025-04-10
• Last updated: 2025-04-10

Locations

1 site across 1 country: China