Healthy person
Conditions
Interventions
AB:Subjects in Sequence AB will receive a single dose of D-1553 under fasting conditions state on Day 1, followed by another dose of D-1553 under fed state on Day 4.
BA:Subjects in Sequence BA will receive a single dose of D-1553 under fasting conditions state on Day 1, followed by another dose of D-1553 under fed state on Day 4.
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible for the enrollment: 1. Male or female, aged 18-45 years (both inclusive) at the time of signing informed consent form. 2. Subjects weight =50.0 kg for males, =45.0 kg for females, 18.5 kg/m2=BMI =26.0 kg/m2, body mass index (BMI)=weight (kg)/height2 (m2). 3. Subjects with normal test results or with abnormal but not clinically significant results as judged by the clinician for medical history, vital signs, physical examination, 12-lead electrocardiogram, chest x-ray at adem position, B-ultrasonography (liver, gallbladder, pancreas, spleen, kidneys), ophthalmological examination, and laboratory tests (including hematology, blood chemistry, coagulation function, blood pregnancy, urinalysis, virological tests)., or those with abnormal but not clinically significant test results as judged by the clinician. 4. Non-smokers or subjects who smoked no more than 5 cigarettes or 1 pipe per day within 3 months prior to screening. 5. Subjects with a negative test result for urine drug abuse (morphine, THC, methamphetamine, MDMA, ketamine) at screening and on Day -1. 6. Those who volunteer to participate in this clinical trial, understand the study procedures and provide signed the Informed Consent Form in writing. 7. Female of childbearing potential must agree to abstain or use two effective contraception methods from 1 month before signing ICF and for the duration of study participation through 180 days after the last dose of investigational drug. Acceptable contraceptive methods include: oral, injected or implanted hormonal methods of contraception (to be used after trial completion); intrauterine device or intrauterine system; condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide. ? A female subject of childbearing potential is any woman, regardless of sexual orientation, who meets the following criteria: a) not surgically sterile with procedures like tubal ligation, hysterectomy, bilateral salpingectomy or bilateral oophorectomy; or b) not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 8. Male subjects must agree to abstain, be surgically sterilized, or agree to use two effective contraceptive methods from the time of signing of ICF and for the duration of study participation through 180 days after the last dose of investigational drug. Effective contraceptive methods include: a) simultaneous use of condom, and for the female partner, hormonal contraceptives or intrauterine contraceptive device (used since at least 4 weeks prior to dosing); b) simultaneous use of condom, and for the female partner, diaphragm or cervical/vault caps with spermicide.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria are not eligible for enrollment: 1. Subjects with previous nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bone and other system diseases; other acute or chronic diseases or mental diseases, and abnormalities judged by the investigator to be clinically significant. 2. Subjects who are positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody, or Treponema pallidum antibody. 3. Subjects who have received vaccine (including the COVID-19 vaccine) within 4 weeks before dosing, or who are expected to receive vaccine during the trial. 4. Subjects with a history of blood or needle phobia. 5. Subjects with a history of dysphagia or any gastrointestinal diseases that may affect drug absorption. 6. Subjects with a history of hypersensitivity to investigational drug and/or any preparation ingredients; or a history of drug/food allergy or allergy-related disease. 7. Subjects who have undergone major surgery affecting the absorption or metabolism of the investigational drug within 6 months prior to the first dose. 8. Subjects who have participated in clinical trials of other investigational drugs within 3 months before the first dose; if the half-life of that other investigational drug is long, the time period is limited to 5 half-lives of the drug. 9. Subjects who have used prescription drugs, over-the-counter drugs, or natural health products (including herbal, homeopathic and traditional medicines, probiotics, dietary supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in exercise) within 14 days prior to the first dose, except for paracetamol (up to 2 g/day) and topical dermal products, including corticosteroid products. 10. Subjects who have used any metabolism inducers (e.g., barbiturate hydrochloride and rifampicin) within 3 months prior to the first dose. 11. Subjects who have used a strong inhibitor or inducer of CYP3A4 (including grapefruit juice, grapefruit, pomegranate, star fruit, pomelo, lime, or fruit juice or manufactured products) within 14 days prior to the first dose. 12. Subjects who are receiving or planning to use the following drugs (see Appendix 2 and Appendix 3): a) Drugs known to be substrates of CYP3A4, CYP2B6, OATP1B1, OATP1B3, and OAT1, b) Drugs known to be inducer or inhibitor of CYP3A4, or c) Drugs known to be strong inhibitor of P-glycoprotein. 13. Subjects unwilling or unable to follow the life restrictions described in the study protocol (such as dietary restrictions, activity and contraceptive requirements). 14. Subjects with average daily consumption of more than 2 units of alcohol (1 unit of alcohol = 360 mL of beer, 150 mL of wine, or 45 mL of liquor), or consumption of drinks or foods (coffee, tea, cocoa, chocolate, cola drinks, etc.) containing xanthine or more than 600 mg caffeine (one cup of 240 mL coffee contains 100 mg caffeine, 1 cup of tea contains 30 mg caffeine, and 1 cup of cola contains 20 mg caffeine) within 3 months before screening. 15. Subjects who have consumed grilled food (charcoal grill) 24 hours before the first dose. 16. Subjects who have undergone blood collection or blood donation during the following periods: a) Whole blood sample = 400 mL: from 90 days before screening examination to admission. b) Whole blood sample = 200 mL:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-8;AUC0-t;maximum observed concentration (Cmax); | — |
Secondary
| Measure | Time frame |
|---|---|
| physical examination;signs and symptoms;blood tests;electrocardiogram (ECG);time to maximum observed concentration (tmax) ;terminal elimination half-life (t1/2); | — |
Countries
China
Contacts
Public ContactAixin Shi
Beijing Hospital
Outcome results
None listed