Idiopathic pulmonary fibrosis
Conditions
Interventions
Single dose study:Single dose study
Food impact research:Food impact research
multiple dose study:multiple dose study
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, non-smokers (not using tobacco or nicotine products within 3 months before screening), = 18 years old and = 65 years old, BMI>18.5 kg/m2 and<26 kg/m2, male weight not less than 50.0 kg, female weight not less than 45.0 kg; 2. Health is defined as: 1) There was no clinically significant disease or operation within 4 weeks before administration. Subjects who vomited within 24 hours prior to the administration of the first study drug will be carefully evaluated for impending illness. The investigator shall decide whether to be selected before administration; 2) No history and condition of nervous, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, kidney, liver and metabolic diseases with clinical significance; 3) No clinically significant abnormality is found in chest X-ray examination; 3. A fertile woman who has an active sexual life with an un sterilized male partner (a sterilized male partner is defined as a man who has undergone vasectomy for at least 6 months) must be willing to use one of the following acceptable contraceptive methods throughout the study period and (the last time, if applicable) within 30 days after the study drug administration: 1) (For the first time) IUDs without hormone releasing system were placed at least 4 weeks before the administration of the study drug, and male partners used condoms at the same time; 2) The contraceptive diaphragm or cervical cap with vaginal spermicide shall be used at least 21 days before the administration of the study drug (the last time, if applicable), and male partners shall use male condoms. 4. Male subjects who had undergone vasectomy for less than 6 months and had active sexual life with fertile female partners (fertile women were defined as women who were neither postmenopausal nor surgically sterilized) must be willing to use one of the following acceptable contraceptive methods at least 90 days after the administration of the study drug (the first time) to (the last time, if applicable): 1) Use male condoms, and female partners start using hormonal contraceptives at least 4 weeks before administration or place IUDs at least 4 weeks before administration; 2) Use male condoms, while female partners use contraceptive diaphragms or cervical caps with vaginal spermicide; 3.) Male subjects with a pregnant partner (including men undergoing vasectomy) must agree to use condoms at least 90 days after the administration of the study drug (first) to (last, if applicable). 5. Male subjects must agree not to donate sperm 90 days after the administration of the study drug (the last time, if applicable); 6. Before the test, learn about the nature, significance, possible benefits, possible inconvenience and potential risks of the test in detail, understand the research procedure and voluntarily sign the informed consent in writing.
Exclusion criteria
Exclusion criteria: 1. During the medical screening period, abnormal physical examination with clinical significance, abnormal laboratory examination results with clinical significance, or positive results of hepatitis B, hepatitis C, syphilis or HIV testing are found; 2. Evidence of clinically significant liver or kidney damage, including but not limited to alanine aminotransferase (ALT) and aspartate aminotransferase (AST) higher than ULN (upper limit of normal), total bilirubin higher than ULN ?- Glutamyltranspeptidase is higher than ULN or creatinine is higher than ULN3); 3. The urine cotinine or drug screening was positive during the screening period; 4. Have a history of significant allergic reaction (such as rapid allergic reaction, obvious respiratory and skin symptoms) or hypersensitivity to any drug, or have a history of allergic reaction to any excipient in the preparation; 5. History of gastrointestinal diseases with clinical significance or history of surgery that may affect drug absorption; 6. Positive pregnancy test in screening period; 7. History of QTc interval prolongation with clinical significance, or QTc interval screening period>470ms for women and>450ms for men; 8. Abnormal vital signs with clinical significance during the screening period (systolic blood pressure less than 90 or more than 140mmHg, diastolic blood pressure less than 50 or more than 90mmHg, or heart rate less than 50 or more than 100bpm); 9. Have a history of serious alcohol abuse within one year before screening or frequently drink alcohol within six months of screening visit (drinking more than 14 units [1 unit=150mL wine, 360mL beer or 45mL 40% alcohol] every week); 10. Have a history of serious drug abuse within one year before screening, or have used soft drugs (such as marijuana) within three months before screening visit, or have used hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives, including heroin and amphetamine derivatives) within one year before screening; 11. Participate in clinical studies involving experimental or marketed drug administration or device use within 30 days before administration, and receive biological drug administration within the context of clinical studies within 90 days before administration, or participate in experimental studies not involving drug administration or device use at the same time; 12. Use drugs within the following specified time range, except for drugs exempted by the investigator according to specific circumstances, because these drugs are judged to be unlikely to affect the PK characteristics of the study drug or the safety of the subject (for example, topical preparations without significant systemic absorption): 1) (For the first time, if applicable) use prescription drugs within 14 days before administration; 2) Use over-the-counter drugs and natural health products (including Chinese herbal medicine, homeopathy and traditional medicine, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in exercise) within 7 days before (the first time, if applicable) administration, except for the occasional use of acetaminophen (up to 2g per day); 3) Carry out depot injection of any drug or implant any drug within 3 months before (the first time, if applicable) administration; 4) Use any drug (including St. John's wort [hypericin]) that is known to induce or inhibit liver drug metabolism within 30 days before (the fi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetics;vital signs;Physical examination;blood routine;Urine routine;Blood biochemistry;Coagulation;ECG;Adverse events; | — |
Countries
China
Contacts
Public ContactYun Cai
Chinese PLA General Hospital
Outcome results
None listed