refractory chronic cough
Conditions
Interventions
Group A:HW091077 tablets (dose 1, qd) : placebo (6:2)
Group B:HW091077 tablets (dose 2, qd) : placebo (6:2)
Group C:HW091077 tablets (dose 3, qd) : placebo (6:2)
Group D:HW091077 tablets (dose 4, qd) : placebo (6:2)
Group E:HW091077 tablets (dose 5, qd) : placebo (6:2)
Group F:HW091077 tablets (dose 6, qd) : placebo (6:2)
Group G:HW091077 tablets (dose 7, qd) : placebo (6:2)
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Subjects fully understand the purpose, nature, methods and possible adverse effects of the trial, volunteer to be a subject and sign an informed consent form before the start of any study procedures; 2) Male and female subjects aged 18 to 55 years (including upper and lower limits) with appropriate sex ratio; 3) Female subjects weighing =45 kg and male subjects weighing =50 kg with a body mass index (BMI) of 19 to 26 kg/m2 (including upper and lower limits); 4) Female subjects of childbearing potential and male subjects whose partner is a woman of childbearing potential are willing to be abstinent or to use a highly effective method of contraception from the time of signing the informed consent until 6 months after the last dose; 5) Those who are able to communicate well with the investigator and who understand and comply with the requirements of this study.
Exclusion criteria
Exclusion criteria: 1) Persons who have had or are currently suffering from any clinically serious disease of the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematologic system, immune system, mental and metabolic abnormalities, or any other disease that, in the judgment of the investigator, may interfere with the results of the trial; 2) Those who have had serious infection, serious trauma or surgery within 3 months prior to screening; those who plan to undergo surgery during the trial and within two weeks of the end of the trial; 3) Those who have abnormalities with clinical significance in vital signs examination, physical examination, chest X-ray, color ultrasound (liver, gallbladder, spleen, pancreas, both kidneys), clinical laboratory tests (routine blood, urine, blood biochemistry, fecal occult blood, coagulation, infection markers, blood alcohol test, drug abuse screening) and 12-lead electrocardiograms; 4) Those with a history of allergy to any component of the study drug; 5) Use of any strong inhibitors and inducers of hepatic metabolizing enzymes within 1 month prior to administration (hepatic metabolizing enzyme inhibitors such as ketoconazole, itraconazole, omeprazole, oxcarbazepine, pemetrexed, modafinil, nevirapine, efavirenz, dexamethasone, psilocycline, pioglitazone, troglitazone, allopurinol, etamivirone, chloramphenicol, chlorpromazine, cimetidine, ciprofloxacin, dextropropoxyphene, diltiazem, ethanol, erythromycin, promethazine, isoniazid, ketoconazole, metoprolol, metronidazole, miconazole, nortriptyline, oral contraceptives, hydroxybutazone, fenestrazine, bupropion, primaquine, propranolol, quinidine, valproate, sulfinpyrazone, sulfonamides, thioridazine, mephedrone, verapamil, etc.; hepatic metabolism enzymes inducer, such as barbiturates, carbamazepine, amlumilte, ashwagandha, aminoglutethimide, phenytoin, grumet, rifampicin, sulfinpyrazone, etc.); 6) Those treated with immunosuppressants or interferon-containing drugs within 6 months prior to administration; 7) Those who have been enrolled in a clinical trial of any drug or medical device within 3 months or 5 half-lives (whichever is longer) prior to screening; 8) Those who have been vaccinated 1 month prior to screening or are scheduled to be vaccinated during the course of the trial or within 1 month after administration; 9) Those who have donated or lost a total of =200 mL of blood within 1 month prior to drug administration or =400 mL of blood within 3 months prior to drug administration; 10) Those who have difficulty in collecting blood intravenously, or whose physical condition cannot withstand intensive blood collection; 11) Those who has a history of tobacco addiction (average of >5 cigarettes per day) in the 3 months prior to screening, or those who are unable to stop using any tobacco-based products during the trial; 12) Those who had an average weekly alcohol intake of more than 15 g (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or approximately 50 mL of low-potency liquor) or a positive results of alcohol breath test in the 3 months prior to screening, or those who were unable to abstain from alcohol during the trial; 13) Those who cannot stop using caffeine-containing foods or beverages (more than 8 cups on average, 1 cup = 250 mL) , or those who have consumed special diets (fruits or corresponding juices containing dragon fruit, mango, lime, grapefruit, and poplar peaches that may affect the drug-met
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| PK outcome; | — |
Countries
China
Contacts
Public ContactWei Hu
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed