Inflammatory Bowel Disease, IBD
Conditions
Interventions
MAD 120 mg:Multiple-ascending dose (SAD), total 12 subjects, 9 receiving PTT-621 and 3 receiving placebo
SAD 30 mg:Single-ascending dose (SAD), total 8 subjects, 6 receiving PTT-621 and 2 receiving placebo
SAD 60 mg:Single-ascending dose (SAD), total 8 subjects, 6 receiving PTT-621 and 2 receiving placebo
SAD 120 mg:Single-ascending dose (SAD), total 8 subjects, 6 receiving PTT-621 and 2 receiving placebo
SAD 180 mg:Single-ascending dose (SAD), total 8 subjects, 6 receiving PTT-621 and 2 receiving placebo
SAD 240 mg:Single-ascending dose (SAD), total 8 subjects, 6 receiving PTT-621 and 2 receiving placebo
SAD 300 mg:Single-ascending dose (SAD), total 8 subjects, 6 receiving PTT-621 and 2 receiving placebo
MAD 180 mg:Multiple-ascending dose (SAD), total 12 subjects, 9 receiving PTT-621 and 3 receiving placebo
MAD 240 mg:Multiple-ascending dose (SAD), total 12 subjects, 9 receiving PTT-621 and 3 receiving placebo
Sponsors
Peking University Third Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be enrolled in this study: 1. Provide a signed and dated informed consent form (ICF). 2. Be able to understand and declare the willingness to abide by all research procedures, be able to participate in the research during the research period, and be willing to complete the research as planned according to the researcher's opinions. 3. At the time of screening, healthy adult men or women aged at least 18 to 55 years old (including the cut-off value) are eligible. 4. The Body Mass Index (BMI) of the subjects ranged from 18.0 kg/m² to 26.0 kg/m² (including the boundary value). 5. Non-smokers or those who have quit smoking - 6. If no clinically significant disease is found in the medical history and no clinically significant examination results are found in the physical examination, vital signs, ophthalmic examination and/or electrocardiogram (ECG), the decision shall be made by the researcher.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria cannot be included in this study: 1. Pregnant or lactating women, or those with positive pregnancy test results before drug administration in the trial. Women who are pregnant or breastfeeding, or those with positive pregnancy test results before study medication; individuals (including their partners) who plan to conceive, donate sperm, or donate eggs within the next three months; individuals who cannot or have not taken effective contraceptive measures approved by the investigator from the first dose to 90 days after the last dose as required by the investigator. 2. Those who have a history of allergy to any component of the research drug or its excipients, or to similar drugs, as well as those who have severe allergic reactions to any drug (such as angioedema, asthma, etc.). 3. Those with major gastrointestinal, liver or kidney diseases or a history of surgery (excluding appendectomy) that may affect the bioavailability, absorption, distribution, metabolism and excretion of drugs. 4. Those with a history of cardiovascular system, respiratory system, digestive system, urinary system, blood and lymphatic system, nervous system, reproductive system, mental disorders, endocrine system, immune system, joint and muscle diseases, breast diseases, ear diseases, eye diseases, thyroid diseases, tumors, metabolic or skin diseases that researchers have determined to be of clinical significance. 5. Individuals with a history of lens opacification (cataracts) or lens degeneration. 6. Those with a surgical or trauma history in the neck that has led to significant changes in the anatomical structure of the thyroid, affecting the interpretation of ultrasound images. 7. Participants evaluated by researchers with abnormal thyroid function tests and/or thyroid ultrasound results that have clinical significance. 8. Those with clinically significant electrocardiogram abnormalities as determined by the researchers during the screening visit. 9. Individuals with a history of chronic inflammatory skin diseases (e.g., psoriasis, atopic dermatitis, drug-related rashes, or chronic urticaria) or autoimmune-related diseases or syndromes. 10. Those who have undergone major surgeries (for example, surgeries requiring general anesthesia) within 12 weeks prior to screening. 11. Those with abnormal renal function during screening, with an estimated glomerular filtration rate of less than 90 mL/min/1.73 m^2 calculated through the formula of the Cooperative Study on Chronic Kidney Disease Epidemiology. 12. Those who are undergoing drug maintenance treatment or have clinically significant drug dependence (Individuals with a history of drug abuse or drug abuse within the last 5 years before the trial). 13. Those with a history of alcohol abuse. 14. The researchers determined that within 28 days prior to the first administration of the study drug, the patient had any clinically significant disease, including acute or chronic infections (such as bacterial, viral, fungal and/or protozoan infections). 15. People who consume excessive amounts of tea, coffee or caffeinated beverages over a long period of time. 16. Those who have consumed any food or beverage containing caffeine, alcohol, xanthine or grapefruit (such as coffee, strong tea, chocolate, etc.) within 72 hours prior to the first administration. 17. If any drug (including traditional Chinese medicine, vitamins and health supplements) was taken for any reason w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse event, AE;Physical examination;ultrasound examination;vital signs;12-lead ECG;Holter;laboratory tests (blood routine, blood biochemistry, thyroid function, urine routine and coagulation function);Pharmacodynamics, PD;C-QTc;Food Effect; | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics, PK; | — |
Countries
China
Contacts
Public ContactHaiyan Li
Peking University Third Hospital
Outcome results
None listed