Lung injury
Conditions
Interventions
Dose Level 1:Single dosing: Inhaled H057 100mg
Multiple dosing: Inhaled H057 100mg, 2 times/day.
Dose Level 2:Single dosing: Inhaled H057 200mg
Multiple dosing :Inhaled H057 200mg, 2 times/day.
Dose Level 3:Single dosing: Inhaled H057 200mg
Multiple dosing :Inhaled H057 200mg, 3 times/day.
Control Group:Single dosing: H057 injection 100mg
Multiple dosing : H057 injection 100mg, 2 times/day.
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Healthy subjects, both male and female in each group; (2) 18 years old = age = 45 years old; (3) Weight: Male weighing no less than 50kg, female weighing no less than 45kg. Body Mass Index (BMI)=Weight (kg)/Height 2 (m2), 19.0kg/m2 = Body Mass Index (BMI) = 26.0kg/m2; (4) During the screening period, the results of vital signs, physical examination, blood routine test, blood biochemistry, blood coagulation function, urine routine test, Virology examination, chest radiograph, blood pregnancy (female) and 12 lead ECG examination showed no abnormality or abnormality without clinical significance; those who have undergone drug abuse screening and alcohol breath test before administration and have no abnormalities; (5) The subjects (including males) have no fertility plan within the next 6 months and voluntarily adopt effective contraceptive measures; (6) The subjects fully understand the purpose, nature, method, and potential adverse events of the experiment, voluntarily participate in the experiment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women, and subjects who have a fertility plan during the trial or within 6 months after the end of the trial; (2) Diseases with chronic history or abnormal clinical manifestations that need to be excluded, including but not limited to diseases of the central nervous system, cardiovascular system, kidney, liver, digestive tract, respiratory system, blood system, metabolism and skeletal muscular system, or any other physiological conditions that can interfere with the test results; (3) Individuals who are allergic to inhaled H057 and its excipients; (4) Within one year prior to screening, there was a significant smoking habit [smoking>5 cigarettes per day; drinking more than 14 units of alcohol per week (1 unit ˜ 200mL of beer with 5% alcohol content, 25mL of spirits with 40% alcohol content, or 85mL of wine with 12% alcohol content)]; (5) Individuals who have participated or are currently participating in clinical trials of other drugs or medical devices within the first 3 months of screening; (6) Individuals with a history of blood donation within one month prior to screening, or those who plan to donate blood or blood components during the study period, or those who experience bleeding due to other reasons, resulting in a total blood loss of = 200mL; (7) Those who have taken any medication (including health products) within 2 weeks before administration; (8) Those who do not smoke, drink alcohol (or alcoholic beverages), drink tea, or coffee from 48 hours before medication to the last blood collection cannot be guaranteed; (9) Difficulties in intravenous infusion or blood collection; (10) The researchers believe that the subjects may not complete this study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tmax;Cmax;AUC; | — |
Countries
China
Contacts
Public ContactWei Zhang
Henan Provincial People's Hospital
Outcome results
None listed