Idiopathic Pulmonary Fibrosis
Conditions
Interventions
SAD group:Five dosage groups with escalating administration
MAD group:Three dosage groups with increasing doses
FE Group: A-B Group:First, take the capsule on an empty stomach. After a 4-day washout period, take the capsule after a high-fat meal.
FE Group: B-A Group:Take the capsule after a high-fat meal, and after a 4-day washout period, take the capsule on an empty stomach.
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1.Age 18~45 years old (including boundary value) Chinese healthy adult male or female; 2.Female weight >= 45 kg, male weight >= 50 kg, and body weight index (BMI) is 19.0~26.0 kg/m^2 (including upper and lower limits); 3.Subjects (or their partners) have no pregnancy plan, sperm and egg donation plan during the trial period and within 3 months after the end of the trial, and agree to take one or more non-drug contraceptive measures (such as complete abstinence, condoms, contraceptive rings, surgical sterilization, etc.); 4.Sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial; 5.Subjects are able to communicate well with the investigator and understand and comply with the requirements of this study;
Exclusion criteria
Exclusion criteria: 1.Those who are allergic to the test preparation and any of its components or related preparations, or have a history of allergy to drugs, foods, or other substances; 2.Those who have any acute or chronic active gastrointestinal or hepatobiliary diseases, or have a history of gastrointestinal or hepatobiliary surgery (excluding appendectomy and inguinal hernia), or other surgeries that affect drug absorption, distribution, metabolism, and excretion; 3.Previous history of cardiovascular system, endocrine system, digestive system, respiratory system, blood and lymphatic system, urinary system, immune system, nervous system or psychiatric disorder, ocular disease or any other medical condition, which is judged by the investigator to be unsuitable for participation in clinical trials; 4.Those with systolic blood pressure >= 140 mmHg and = 90 mmHg and 450 ms (males) or >470 ms (females), or QRS interval >120 ms; 5.Those who have had fever and other symptoms of infection within 28 days before the first dose; 6.Subjects with a prior history of hepatitis, or a positive test for hepatitis B surface antigen (HepBsAg), hepatitis C antibody (HCVAb), or human immunodeficiency virus antibody (HIVAb) at screening; 7.Non-physiologic blood loss >= 300 mL (including trauma, blood collection, blood donation, or blood components) within 14 days prior to the first dose; or Those who plan to donate blood or blood components during the trial or within 30 days after the last dose; 8.Lactose intolerant (those who have had diarrhea from drinking milk); 9.Use of any medication that affects hepatic CYP3A metabolizing enzymes, such as: inhibitor-ketoconazole, ritonavir, clarithromycin, grapefruit juice (in large quantities, such as >1 liter per day, or high concentrations) within 28 days prior to screening; Inducers - carbamazepine, phenobarbital, phenytoin, rifampicin, St. John's wort (also known as Hyperechinensis, St. John's wort) extract; 10.Those who have been vaccinated within 4 weeks prior to the first dose, or who plan to be vaccinated within 4 weeks after the last dose; 11.Those who have used prescription drugs, prescription drugs, Chinese herbal medicines, or excess vitamins within 14 days or 5 half-lives (whichever is longer) before the first dose of the investigational drug (except for those that have no effect on the results of the study as judged by the investigator); 12.Those who have a history of drug abuse or drug abuse within 6 months prior to screening, or who have a positive drug abuse screen; 13.Excessive alcohol consumption of more than 14 drinks per week (1=150 mL of wine, or 360 mL of beer, or) within 3 months prior to screening 45 mL of spirits), or those who have a positive blood alcohol test during the screening period; or unwilling to stop drinking alcohol or any alcoholic products during the trial; 14.Smokers or those who smoked more than 5 cigarettes per day in the 3 months prior to the use of the trial drug, or those who cannot stop using any tobacco products during the study period; 15.Those who have participated in other drug clinical trials or enrolled in any drug/medical device clinical trial within 3 months prior to screening; 16.Physical examination, electrocardiogram, anteroposterior chest x-ray, abdominal ultrasound, vital signs, laboratory tests, etc. are abnormal Those who are clinically significa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability indicators; | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentrations; | — |
Countries
China
Contacts
Public ContactHu Wei
The Second Hospital of Anhui Medical University
Outcome results
None listed