Aspergillosis
Conditions
Interventions
Single ascending dose for healthy subjects (20 mg):4 subjects (half male and half male) were divided into 2 groups, 1 male and 1 female in each group, and were randomly assigned to receive the experim
Single ascending dose for healthy subjects (40 mg):10 subjects, with a male to female ratio of 1:1, were randomly assigned to receive the trial drug or placebo in a 4:1 ratio.
Single ascending dose for healthy subjects (80 mg):10 subjects, with a male to female ratio of 1:1, were randomly assigned to receive the trial drug or placebo in a 4:1 ratio.
Single ascending dose for healthy subjects (160 mg):10 subjects, with a male to female ratio of 1:1, were randomly assigned to receive the trial drug or placebo in a 4:1 ratio.
Multi-dose escalation for patients with mild stable asthma (40mg):10 subjects were enrolled, with a male to female ratio of 1:1, and were randomly assigned to receive the trial drug or placebo in a 4:
Multi-dose escalation for patients with mild stable asthma (80mg):10 subjects were enrolled, with a male to female ratio of 1:1, and were randomly assigned to receive the trial drug or placebo in a 4:
Multi-dose escalation for patients with mild stable asthma (160mg):10 subjects were enrolled, with a male to female ratio of 1:1, and were randomly assigned to receive the trial drug or placebo in a 4
Two-cycle crossover test:The proposed trial drug dose is 80 mg, and 16 patients with mild to moderate stable asthma are planned to be included, with a male to female ratio of 1:1. The trial was divide
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: First part 1. The subjects can understand the procedures and methods of this clinical trial, obtain full informed consent, voluntarily participate, and have the subjects themselves sign the informed consent form. 2. Healthy male or female subjects aged 18 to 65 years old (including the critical value) when signing the informed consent form; body mass index (BMI) between [19.0 ~ 26.0]kg/m2 (including the critical value). 3. Pulmonary function test: FEV1 = 80% of the predicted value or FVC = 80% of the predicted value. 4. The subject voluntarily takes effective contraceptive measures (including the subject’s partner) from the screening period to 3 months after the last dose (see Appendix 2 for details on the measures), and has no childbearing plans or donations in the next 3 months. Sperm and egg donation program. 5. The subject can communicate well with the researcher, can correctly use the powder mist inhalation device, and understand and comply with the requirements of this study. Second part 1. The subjects can understand the procedures and methods of this clinical trial, obtain full informed consent, voluntarily participate, and have the subjects themselves sign the informed consent form. 2. Men or women aged 18 to 65 years old (including the critical value) when signing the informed consent form; body mass index (BMI) between [19.0 ~ 30.0]kg/m2 (including the critical value). 3. According to the definition of China's "Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 Edition)", the patient is diagnosed with mild asthma and is in the clinical control period as assessed by the researcher. 4. Those who have positive results for any objective examination of variable airflow limitation performed within 1 year before screening; or the screening period must meet the requirement of a positive bronchodilation test, that is, the FEV1 increases by >12% after inhaling 400 µg of albuterol for 15 to 30 minutes, and the FEV1 The absolute value increases >200mL (if the bronchodilation test result does not reach the positive threshold, another bronchodilation test is allowed within 7 days after the examination (excluding the day of examination)); or the average daily maximum expiratory flow (PEF) during the screening period Diurnal variation rate >10%, or weekly variation rate >20%; 5. At the time of screening, no smoking history, or current smoking cessation for at least one year (including: cigarettes, cigars, pipe tobacco, etc.), smoking history =10 pack-years [Smoking index (pack-year) = daily smoking volume (pack) × Smoking time (years), 1 pack = 20 cigarettes]; and those who do not use any tobacco products during the trial. 6. The subject voluntarily takes effective contraceptive measures (including the subject's partner) from the screening period to 3 months after the last dose (see Appendix 2 for specific measures), and has no childbearing plans or donations in the next 3 months. Sperm and egg donation program. 7. The subject can communicate well with the researcher, can correctly use the powder mist inhalation device, and understand and comply with the requirements of this study. Third Part 1. The subjects can understand the procedures and methods of this clinical trial, obtain full informed consent, voluntarily participate, and have the subjects themselves sign the informed consent form. 2. Men or women aged 18 to 65 years old (including the critical value) when signing the informed consent form; body mass index (BMI) w
Exclusion criteria
Exclusion criteria: First part 1. Allergy or intolerance to voriconazole, other antifungal azole drugs, or any component of the drugs used in this trial (such as those with congenital fructose intolerance, sucrase-isomaltase deficiency or glucose-galactose malabsorption ) or those with a history of idiopathic reactions, or those with allergies (such as allergies to two or more drugs, food or pollen). 2. Have suffered or are currently suffering from chronic or serious diseases of the liver, kidney, endocrine, urinary system, digestive system, blood and lymphatic system, respiratory system, cardiovascular system, nervous system, mental illness, diabetes, tuberculosis and other above-mentioned systems. By. 3. Previous mental disorders are not limited to schizophrenia, paranoid disorder, panic disorder, obsessive-compulsive disorder, insomnia, behavioral will disorder, postpartum mental disorder, paranoid mental disorder and neurological disorders associated with various organic diseases, etc. , such as Alzheimer's disease, convulsions, epilepsy, etc. 4. Confirmed or suspected upper or lower respiratory tract infection, sinusitis, or otitis media within 1 month (30 days) before screening or before randomization. 5. Those who have used any drugs (including prescription drugs, over-the-counter drugs, vitamin supplements or Chinese herbal medicines), health products or vaccines within 1 month (30 days) before screening. 6. Those who have undergone major surgery within 3 months (90 days) before screening, or those who have undergone surgery that may significantly affect the in vivo process or safety evaluation of the study drug. 7. Within 3 months (90 days) before screening, the average daily alcohol consumption exceeds 2 units of alcohol [1 unit = 360mL beer or 45mL liquor with 40% alcohol content or 150mL wine]; or cannot abstain from drinking during the trial; or Those with positive alcohol breath test results (alcohol content >0mg/100mL). 8. Smokers within 3 months (90 days) before screening, or those who cannot stop using any tobacco products during the trial, or those with positive nicotine screening results. 9. Those who have participated in drug or device clinical trials and received experimental drugs (except placebo) or device treatment within 3 months (90 days) before screening. 10. Those who donated blood or lost a large amount of blood (>400mL) within 3 months (90 days) before screening. 11. In the 3 months (90 days) before screening, excessive intake of tea, coffee or caffeinated beverages per day (average =8 cups per day, 250mL per cup). 12. Those who have a history of drug abuse and drug dependence within 1 year before screening. 13. Those with positive drug abuse screening results (morphine, methamphetamine, ketamine, methylenedioxyamphetamine, tetrahydrocannabinolic acid). 14. Those with clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram, full chest X-ray, blood routine, urine routine, and blood biochemical results. 15. Those with positive virology (HBsAg, HCV antibody, HIV antibody, Treponema pallidum antibody) test results. 16. Women with positive pregnancy test results or lactating women; or female subjects who have used long-acting estrogen or progesterone injections or implants within 6 months before screening. 17. You cannot avoid consuming xanthine-rich beverages (coffee, tea, etc.) or food (chocolate, animal liver, etc.) 48 hours before administration until the end of the study, or consumi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters after single dose;Pharmacokinetic parameters after multiple doses; | — |
Countries
China
Contacts
Public ContactLiu Jian, Zhou Jianya
The First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed