Idiopathic pulmonary fibrosis, IPF
Conditions
Interventions
SAD 50mg:JK1033 tablets / placebo 50 mg single dose
SAD 150mg:JK1033 tablets / placebo 150 mg single dose
SAD 300mg:JK1033 tablets / placebo 300 mg single dose
SAD 600mg:JK1033 tablets / placebo 600 mg single dose
SAD 800mg:JK1033 tablets / placebo 800 mg single dose
MAD 150mg:JK1033 tablets / placebo 150 mg bid for 7.5 days
MAD 300mg:JK1033 tablets / placebo 300 mg bid for 7.5 days
MAD 400mg:JK1033 tablets / placebo 400 mg bid for 7.5 days
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Volunteers are fully informed of the study details and are willing to participate and sign the informed consent form (ICF) prior to any study procedure. 2.Healthy male and female volunteers, aged between 18 and 55 years (inclusive) at the time of signing the informed consent form (ICF).The proportion of a single gender should not be less than one third. 3.Body mass index (BMI) range within 19 ~ 28 kg/m^2 (inclusive), and body weight of >= 50.0 kg for male and >= 45.0 kg for female. 4.Generally good health status based on medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory tests. 5.Volunteers considered fertile must agree to use effective contraceptive methods from the screening period through 90 days after the last dose of the IP. During this period, female volunteers must refrain from egg collection or donation; male volunteers must agree not to father a child or donate sperm. Additionally, fertile male or female partners must also agree to use effective methods of contraception measures during this period. 6.Volunteers shall be able to communicate well with the Investigator (or Sub-investigator), as well as understand and adhere to the requirements of this study.
Exclusion criteria
Exclusion criteria: 1. Difficulties in venous blood collection or a history of dizziness when encountering blood or needles. 2. Known or suspected pregnancy, or planned pregnancy during the study period, a positive pregnancy test at screening or on Day -1, or are breastfeeding. 3. Known or suspected to have hypersensitivity to drugs or other things, or is known or suspected to have hypersensitivity to any ingredient in the JK1033 tablets and/or JK1033. 4. Receipt of an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 3 month or 5 times the half-life (whichever is longer) prior to the first dose of IP. 5. A history of gastrointestinal (such as duodenal ulcer, alimentary tract hemorrhage, gastroesophageal reflux disease (GERD), etc.), liver or kidney disease, or other conditions known to interfere with drug absorption, distribution, metabolism, or excretion as determined by the Investigator (or Sub-investigator). 6. Major surgery within 3 months prior to the first dose of IP or plans to undergo surgery during the study. 7. A medical history (including past and present) of other significant diseases (including but not limited to pulmonary, cardiovascular, gastrointestinal, hematological, endocrinological and metabolic disease, immunological, dermatological, malignant diseases, mental and nervous system diseases, and other related diseases), or any other unsuitable participation disease/ailment at the discretion of the Investigator (or Sub-investigator). 8. Any of the following clinical laboratory test results at screening or on Day -1: ? Alanine aminotransferase (ALT) > 1.5 × ULN; ? Aspartate aminotransferase (AST) > 1.5 × ULN; ? Serum creatinine > 1.2 × ULN; or creatinine clearance 450 ms, female > 470 ms) at screening or on Day -1. 10. Has risk factors for torsade de pointes (TdP) in medical history (such as heart failure, hypokalaemia, hypomagnesemia, a family history of long Q-T syndrome, etc.). 11. Any medication (prescription and nonprescription) within 14 days or 5 times the half-life (whichever is longer) prior to the first dose of IP. (Excluding oral contraceptives, or topical ointments at the discretion of the Investigator (or Sub-investigator)). 12. A known history of drug abuse within 2 years before the screening; or positive drug abuse test at screening. 13. Blood donation or blood loss (except for menstrual blood loss in females) of more than 400 mL within 3 months before the screening. 14. Weekly alcohol consumption of more than 14 units of alcohol (1 unit of alcohol = 360 mL of beer or 45 mL of spirit with the alcohol content of 40% or 150 mL of wine) at any time within the past 3 months before screening; or intake of alcohol-containing products within 48 hours prior to the first dose of IP, or cannot abstain from any alcohol product during the study, or positive breath alcohol test at screening or on Day -1. 15. Smoking history (= 5 cigarettes per day) within 3 months before the screening, or cannot abstain from any tobacco products during the study. 16. Excessive drinking of tea, coffee, or caffeine-containing beverages (at least 8 cups per day, 1 cup = 250 mL) within 3 months before screening; intake of food or drinks rich in caffeine or xanthine (e.g., coffee, tea, chocolate, cola drinks) within 48 hours prior to the first dose of IP. 17. Positive screening t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic, PK;Safety; | — |
Countries
China
Contacts
Public ContactHaiyan Li, Cheng Cui
Peking University Third Hospital
Outcome results
None listed