Refractory or unexplained chronic cough
Conditions
Interventions
400 mg dose group:Oral administration of QR052107B tablets or matching placebo
25 mg dose group:Oral administration of QR052107B tablets or matching placebo
100 mg dose group:Oral administration of QR052107B tablets or matching placebo
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects who can understand and are willing to strictly abide by the clinical trial protocol to complete the trial and sign the informed consent form. 2. Male and female subjects aged 18 to 65 years old (including both upper and lower limits), with an appropriate gender ratio. 3. Female subjects weigh >= 45 kg, male subjects weigh >= 50 kg, and their body mass index (BMI) is 19–26 kg/m² (including the upper and lower limits). 4. The result of the blood human chorionic gonadotropin (HCG) pregnancy test for women of childbearing age during screening is negative. 5. The subjects and their sexual partners are willing to have no childbearing plans from 2 weeks before screening to 6 months after the last administration of the study drug, voluntarily take effective contraceptive measures, have no plans to donate sperm or eggs, and ensure that they use one or more non-pharmacological contraceptive measures during sexual activity from 2 weeks before screening to 1 month after the last administration of the study drug.
Exclusion criteria
Exclusion criteria: 1. It is known that those who have a history of allergies to the excipients of QR052107B, QR052107B tablets, or drugs with chemical structures/categories similar to QR052107B, or have a previous history of drug or food allergies. 2. Female subjects who are breastfeeding. 3. Female subjects who have experienced menstrual disorders in the past three months. 4. Screen those who have been enrolled in any clinical trial in the previous 3 months. 5. Select those who are frequent drinkers within the first 3 months, i.e., consuming more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine); or those with positive blood alcohol test results during the screening period. 6. Those who have special dietary requirements and cannot accept a unified diet; or those with poor compliance. 7. Those who cannot tolerate venipuncture; those with a history of fainting due to needle or blood phobia; or those with poor vascular conditions. 8. Non-physiological blood loss of >= 500 ml within 60 days before screening (including trauma, blood collection, blood donation); non-physiological blood loss of >= 50 ml within 14 days before screening (including trauma, blood collection, blood donation); or planned blood donation during the trial or within 30 days after taking the medication. 9. Screen out subjects who have had major diseases considered clinically significant by the researcher within 90 days before screening. 10. Screen those who have undergone surgery within the previous 60 days or plan to undergo surgery during the study period. 11. Screen those with a history of acute infection within the previous 28 days. 12. Screen those who have a history of vaccine within the previous 28 days or plan to be vaccinated during the study period. 13. Screen those who have used any drugs (including prescription drugs, over-the-counter drugs, dietary supplements, etc., especially substrates or inhibitors of CYP3A4 metabolic enzymes listed in Appendix I) within the first 28 days. 14. Screen those who have an average smoking amount of more than 5 cigarettes per day in the previous 3 months or those who cannot stop using any tobacco products during the trial period. 15. Those with a history of drug abuse, dependence, or drug addiction, or those who test positive in the urine drug screening during screening. 16. Those with clinically significant abnormalities in any one of the following infections: hepatitis B virus (HBV) infection, hepatitis C virus (HCV) infection, human immunodeficiency virus (HIV) infection, or Treponema pallidum infection. 17. Diseases with abnormal clinical manifestations that may have occurred or are occurring before screening and need to be excluded, including but not limited to diseases of the digestive tract, liver, or kidneys, which may affect the intake, transport, absorption, distribution, or metabolism of the trial drug or may increase the risk to subjects (such as dysphagia, uncontrollable nausea and vomiting, active gastric ulcer, ulcerative colitis, Crohn's disease, chronic diarrhea, intestinal obstruction, thyroid disease, ovarian disease, etc.). 18. Screen those who had abnormal or significant changes in taste perception in the previous month, or those who scored less than 2 points in any single item of the taste chemical test during screening. 19. Those with clinically significant abnormalities in physical examination, vital sign detection, 12-lead electrocardiogram, labo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events, adverse drug reactions, and serious adverse events;Number of participants and events with drug-related SAEs, Grade 2 or higher AEs, and Grade 3 or higher AEs; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters of QR052107B after the first dose (Cmax, Tmax, and AUC0-24h);Pharmacokinetic parameters of QR052107B after multiple dosing and the last dose (Cmax, Tmax, AUC0-24h, AUClast, AUC0-inf, Vz/F, CL/F, Cmin, Cav, PTF, Rac, t1/2, and MRT); | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed