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

NCT06213363 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-01-19

No results posted yet for this study

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.

Conditions

  • Refractory Chronic Cough

Interventions

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.

Sponsors & Collaborators

  • Beijing Tide Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-10-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06213363 on ClinicalTrials.gov