1 Primary Biliary Cholangitis, PBC, 2 NASH
Conditions
Interventions
Group 1:The first group (pre-test) 2 subjects, 2 patients received the test drug, 1 case for male and female, once administered, administered under fasting conditions, and evaluated for tolerance at D
Group 2:In the second group of 10 subjects, 8 received the test drug and 2 received the placebo. The male to female ratio was close.Once administered, The drug was administered under fasting condition
Group 3:In the third group of 10 subjects, 8 received the test drug and 2 received the placebo. The male to female ratio was close.Once administered, The drug was administered under fasting conditions
Group 4:In the fourth group of 10 subjects, 8 received the test drug and 2 received the placebo. The male to female ratio was close.Once administered, The drug was administered under fasting condition
Group 5:In the fifth group of 10 subjects, 8 received the test drug and 2 received the placebo. The male to female ratio was close.Once administered, The drug was administered under fasting conditions
Group 6:In the sixth group of 10 subjects, 8 of them received the test drug and 2 received the placebo. The male to female ratio was close.Once administered, The drug was administered under fasting co
Group 7:In the seventh group of 10 subjects, 8 of them received the test drug and 2 received the placebo. The male to female ratio was close.Once administer
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Sign the informed consent form before the trial and fully understand the test content, process and possible adverse reactions; 2) Ability to complete the study as required by the protocol; 3) Subjects (including partners) are willing to take effective contraceptive measures from the screening to the last study drug administration within 6 months. See the appendix for specific contraceptive measures; 4) Male and female subjects aged 18-55 years (including 18 and 55 years old); 5) Male subjects weigh no less than 50 kg and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index in the range of 18 ~ 28kg / m2 (including the threshold); 6) Physical examination, normal or abnormal vital signs have no clinical significance; 7) Laboratory tests: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) = 1 times ULN.
Exclusion criteria
Exclusion criteria: 1) More than 5 cigarettes per day for the first 3 months of the trial; 2) Allergies (multiple drugs and food allergies); 3) History of drug use and/or alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 ml of wine); 4) Donate blood or massive blood loss (> 450 mL) within the first three months of screening; 5) taking any drug that changes liver enzyme activity 28 days before screening; 6) Take any prescription, over-the-counter, any vitamin product or herbal medicine within 14 days prior to screening; 7) Take special diet (including dragon fruit, mango, grapefruit, etc.) within 2 weeks before screening, or have strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 8) Inhibitors or inducers of the following CYP3A4, P-gp or Bcrp, such as itraconazole, ketoconazole or dronedarone; 9) There have been major changes in diet or exercise habits recently; 10) Take the research drug or participate in the drug clinical trial within three months before taking the study drug; 11) Have a history of dysphagia or any history of gastrointestinal disease affecting drug absorption or have a history of cholecystectomy or biliary tract disease; 12) suffer from any disease that increases the risk of bleeding, such as acne, acute gastritis or stomach and duodenal ulcers; 13) Subjects who cannot tolerate standard meals (two boiled eggs, one slice of butter bacon toast, one box of fried potato strips, one cup of whole milk) (this article applies only to subjects participating in postprandial trials) ; 14) ECG abnormalities have clinical significance; 15) Female subjects are in lactation or positive for serum pregnancy during the screening period or during the trial; 16) Clinical laboratory tests have clinically significant abnormalities, or other clinical findings that show clinical significance within 6 months prior to screening (including but not limited to gastrointestinal, renal, hepatic, neurological, blood, endocrine, tumor, lung) , immune, mental or cardiovascular and cerebrovascular diseases); 17) Screening for viral hepatitis (including hepatitis B and hepatitis C), AIDS antibodies, and Treponema pallidum antibodies; 18) Acute illness or concomitant medication from the screening stage to the study drug; 19) Ingested chocolate, any caffeine-containing or jaundice-rich food or drink 48 hours prior to taking the study drug; 20) Take any alcoholic products within 48 hours prior to taking the study medication; 21) Those who are urinary sieve-positive or have a history of drug abuse or drug use in the past five years; 22) The investigator believes that there are other subjects who are not eligible to participate in the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma concentration;ALP;Fibroblast growth factor;FGF-19;BA precursor C4 (7a-hydroxy-cholest-4-ene-3-one);Serum cholesterol;bile acid; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital of Jilin University
Outcome results
None listed