Progressive fibrotic interstitial lung disease
Conditions
Interventions
A1 experimental drug group:Administer the experimental drug through nebulization inhalation
A1 placebo group:Nebulized inhalation provides placebo
A2 experimental drug group:Administer the experimental drug through nebulization inhalation
A2 placebo group:Nebulized inhalation provides placebo
A3 experimental drug group:Administer the experimental drug through nebulization inhalation
A3 placebo group:Nebulized inhalation provides placebo
A4 experimental drug group:Administer the experimental drug through nebulization inhalation
A4 placebo group:Nebulized inhalation provides placebo
A5 experimental drug group:Administer the experimental drug through nebulization inhalation
A5 placebo group:Nebulized inhalation provides placebo
Sponsors
Beijing Chao-Yang Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Healthy male and female participants aged 18 to 45 years (including the threshold); 2. Male weight >= 50.0 kg, female weight >= 45.0 kg; Body mass index (BMI) within the range of 19.0-26.0 kg/m^2 (including critical values); 3. The subjects (including male subjects) have no fertility plans and voluntarily adopted effective contraceptive measures during the trial period and within 3 months after the last dose, and have no plans to donate sperm or eggs; 4. The subjects fully understand the purpose, nature, process, and potential adverse reactions of the trial, voluntarily participate as subjects, communicate well with the researchers, comply with the requirements of the entire study, and sign an informed consent form before any research procedure begins; 5. After training during the screening period, be able to breathe as required during inhalation administration.
Exclusion criteria
Exclusion criteria: 1. Allergic constitution, such as a known history of allergies to two or more drugs, two or more foods, or a known history of allergies to inhaled HTPEP-001 and related excipients (consultation); 2. Screening for individuals with a history of chronic or severe diseases such as cardiovascular, liver, kidney, biliary, respiratory, blood and lymphatic, endocrine, immune, psychiatric, neuromuscular, gastrointestinal system, etc. from 1 year prior to randomization, or with a history of gastrointestinal diseases (including existing ones) from 1 year prior to screening to randomization, including chronic or active upper gastrointestinal diseases such as esophageal disease, gastritis, duodenitis, gastrointestinal ulcers, or active gastrointestinal bleeding or gastrointestinal surgery (consultation); 3. During screening, vital signs examination, physical examination, clinical laboratory examination (including blood routine, urine routine, blood biochemistry, coagulation function, and infectious diseases), 12 lead electrocardiogram examination, abdominal ultrasound, and chest X-ray examination were conducted. The results were judged by the researcher to be clinically significant if there were abnormalities (examination); 4. Screening for individuals who have developed acute illnesses between the two weeks prior to randomization (consultation); 5. Screening for individuals who have used any medication (including prescription drugs, over-the-counter drugs, herbal preparations, and prescriptions) and health supplements between 2 weeks prior to randomization (consultation); 6. Screening for individuals who have consumed strong tea, caffeinated, alcoholic beverages, or foods such as chocolate, dragon fruit, mango, starfruit, guava, grapefruit, orange, grapefruit, or grapefruit products that affect drug metabolism within the first 2 weeks to 48 hours before administration (consultation); 7. Screening individuals who have undergone major surgical procedures (excluding diagnostic surgical procedures) within the first 6 months prior to randomization, or who plan to undergo surgery during the study period, or who have undergone surgery that the researcher determines will affect drug absorption, distribution, metabolism, and excretion (consultation); 8. Screening for individuals who have received attenuated live vaccines before 2 weeks prior to randomization or who need to receive attenuated live vaccines during the trial period (consultation); 9. Screening for participants who have participated in other clinical trials between the previous 3 months and randomization (note: the end time is defined as the date of the last participation in the clinical trial) (consultation, plagiarism check); 10. Screening for individuals who have donated blood within the past 3 months up to randomization, those who have donated blood within the past 6 months, or those who have lost a total of 400 mL or more due to other reasons (excluding menstrual bleeding in females), and those who plan to donate blood within 1 month after the last dose (consultation); 11. In the past year, people who drink more than 2 units of alcohol per week on average (1 unit=360 mL beer or 45 mL Baijiu or 150 mL wine with 40% alcohol), or can not abstain from drinking during the test, or the alcohol breath test result is greater than 0.0 mg/100 mL (consultation, examination); 12. Those who cannot stop using any tobacco products during the trial period, or those who test positive for tobacco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of Adverse Event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic characteristics;Immunogenicity after administration;The production of anti-drug antibody after administration; | — |
Countries
China
Contacts
Public ContactWang Shumin
Beijing Chao-Yang Hospital, Capital Medical University
Outcome results
None listed