NCT06213363

A Phase Ib/II Clinical Study in Patients With Refractory Chronic Cough

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ib/II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of TCR1672 Tablets in Patients With Refractory Chronic Cough

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Beijing Tide Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled Phase Ib/II clinical trial to evaluate the effectiveness, safety, tolerability and pharmacokinetics (PK) of TCR1672 Tablets in patients with refractory chronic cough.

Detailed description

All potential participants proceed to the screening period (7-14 days) after voluntarily signing the informed consent form, and the investigators conduct eligibility assessment for the participants as per the inclusion and exclusion criteria. 72patients with RCC are planned to be enrolled in this study. All participants will firstly be randomized at a ratio of 1:1:1 to receive one of the three oral doses of three times a day TCR1672 (20mg, 40mg, 60mg). Then patients will further be randomized to two treatment sequences, Dosing Sequence 1 and Dosing Sequence 2. Participants in Dosing Sequence 1 will be given TCR1672 Tablets for 1 weeks, followed by a 1-week washout period, and then crossover to 1-week placebo treatment. Participants in Dosing Sequence 2 will be firstly administered 1-week placebo treatment, followed by a 1-week washout period, and then crossover to TCR1672 tablets for 1-week treatment. TCR1672 Tablets will be administered orally after meal. No dose adjustments are allowed during the study.

Conditions

• Refractory Chronic Cough

Interventions

Type	Name	Description
DRUG	TCR1672 tablet	All potential participants proceed to the screening period (7-14 days) after voluntarily signing the informed consent form, and the investigators conduct eligibility assessment for the participants as per the inclusion and exclusion criteria. 72patients with RCC are planned to be enrolled in this study. All participants will firstly be randomized at a ratio of 1:1:1 to receive one of the three oral doses of three times a day TCR1672 (20mg, 40mg, 60mg). Then patients will further be randomized to two treatment sequences, Dosing Sequence 1 and Dosing Sequence 2. Participants in Dosing Sequence 1 will be given TCR1672 Tablets for 1 weeks, followed by a 1-week washout period, and then crossover to 1-week placebo treatment. Participants in Dosing Sequence 2 will be firstly administered 1-week placebo treatment, followed by a 1-week washout period, and then crossover to TCR1672 tablets for 1-week treatment.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2024-01-19
• Last updated: 2024-01-19