[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629614":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":29,"centralContacts":34,"locations":40,"responsibleParty":57,"collaborators":28,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":28,"eligibilityCriteria":65,"healthyVolunteers":66,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":28,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":28,"overallStatus":79,"whyStopped":28,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Forward Pharmaceuticals Co., Ltd.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Sequence 1","EXPERIMENTAL","Enrolled subjects will be administered the study drug under fasting conditions (fasted for at least 10 hours, with water allowed as needed) on Day 1 of Cycle 1, followed by a follow-up period and the washout period. They will then proceed to Cycle 2, where the study drug will be administered on Day 1 after consuming a low-fat meal (total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content), again followed by a follow-up period and the washout period. Subsequently, in Cycle 3, the study drug will be administered on Day 1 after consuming a high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), followed by the final follow-up period.",[13],"Drug: FWD1802",{"label":15,"type":10,"description":16,"interventionNames":17},"Sequence 2","Enrolled subjects will be administered the study drug on Day 1 of Cycle 1 after consuming a low-fat meal (total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content), followed by a follow-up period and the washout period. They will then proceed to Cycle 2, where the study drug will be administered on Day 1 after consuming a high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), again followed by a follow-up period and the washout period. Subsequently, in Cycle 3, the study drug will be administered on Day 1 under fasting conditions (fasted for at least 10 hours, with water allowed as needed), followed by the final follow-up period.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Sequence 3","Enrolled subjects will be administered the study drug on Day 1 of Cycle 1 after consuming a high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), followed by a follow-up period and the washout period. They will then proceed to Cycle 2, where the study drug will be administered on Day 1 under fasting conditions (fasted for at least 10 hours, with water allowed as needed), again followed by a follow-up period and the washout period. Subsequently, in Cycle 3, the study drug will be administered on Day 1 after consuming a low-fat meal (total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content), followed by the final follow-up period.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","FWD1802","Single-dose of 150 mg of FWD1802.",[9,15,19],null,[30],{"name":31,"affiliation":32,"role":33},"Yanmei Liu","Shanghai Xuhui Central Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Limin Yin","CONTACT","+86 18520159114","yinlm@forward-pharm.com",[41],{"facility":32,"status":28,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Shanghai","Shanghai Municipality","200032","China","CN",{"type":48,"coordinates":49},"Point",[50,51],121.45806,31.22222,{"lat":51,"lon":50},[54],{"name":31,"role":37,"phone":55,"phoneExt":28,"email":56},"+86 13564045062","ymliu@shxh-centerlab.com",{"type":58,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100629614","phase-1-evaluation-of-the-food-effecton-the-pharmacokinetics-of-fwd1802-in-healthy-subjects-100629614",false,"NCT07476963","Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects","A Phase I, Single-Center, Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Effect of High-Fat and Low-Fat Meals on the Pharmacokinetics of FWD1802 in Chinese Healthy Subjects","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n\n  1. The subject understands the trial's objectives, nature, methods, and potential adverse reactions, voluntarily participates, and signs the informed consent form, ensuring that all trial procedures will be personally undertaken by the subject.\n  2. Chinese male or female subjects, aged 18-45 years (inclusive) for males and 18-50 years (inclusive) for females at the time of screening.\n  3. Body mass index (BMI) between 19.0 and 28.0 kg\u002Fm² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.\n  4. Results from screening assessments, including medical history inquiry, vital signs \\[body temperature (tympanic), pulse, blood pressure (seated)\\], comprehensive physical examination, laboratory tests (complete blood count, blood chemistry, urinalysis, coagulation function), 12-lead electrocardiogram (ECG), abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys), and chest X-ray (posteroanterior view), are all within normal limits or show abnormalities that are not clinically significant.\n  5. Female subjects have no pregnancy plan and voluntarily agree to use effective contraceptive measures (Appendix 1) from 2 weeks prior to the first dose until 6 months after the last dose \u002F Male subjects have no pregnancy plan for their partners and voluntarily agree to use effective contraceptive measures (Appendix 1) from the first dose until 6 months after the last dose, with no plans for sperm or egg donation.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be eligible for enrollment in this study:\n\n  1. History or presence of clinically significant diseases requiring exclusion, including but not limited to disorders of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, psychiatric, ophthalmological, respiratory, metabolic, and skeletal systems.\n  2. History of severe allergies (including allergic constitution, drug allergies, allergies to two or more types of food, etc.) or known hypersensitivity to FWD1802 and\u002For any of its excipients.\n  3. Special dietary requirements or inability to tolerate a high-calorie (approximately 800-1000 Kcal per meal) and high-fat (fat constituting approximately 50% of total caloric intake) diet.\n  4. History of dysphagia or any gastrointestinal disease that may affect drug absorption (including but not limited to gastrointestinal dysfunction, total\u002Fpartial gastrectomy, gastrointestinal bleeding\u002Fulcer, malabsorption syndrome, uncontrolled nausea\u002Fvomiting\u002Fdiarrhea, etc.).\n  5. Undergone surgery within 3 months prior to screening or planned surgery during the study period.\n  6. Intolerance to venipuncture, history of needle phobia\u002Fblood phobia, or difficulty with blood collection.\n  7. History of drug abuse or positive urine drug abuse screening (at baseline).\n  8. Regular alcohol consumption exceeding 21 units per week within 3 months prior to screening (1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of 40% spirits) or positive alcohol breath test (at baseline).\n  9. Smoking history of more than 10 cigarettes per day within 3 months prior to screening.\n  10. Excessive consumption of tea, coffee, and\u002For caffeine-rich beverages (average \\>8 cups per day, 1 cup = 250 mL) within 3 months prior to screening.\n  11. Donated blood or experienced significant blood loss (≥400 mL), or received blood transfusion or blood products within 3 months prior to the first dose.\n  12. Participation in another clinical trial involving an investigational drug and receipt of the study drug within 3 months prior to the first dose, with an interval less than 5 half-lives of the previously administered drug.\n  13. Use of any moderate\u002Fstrong CYP3A4 inhibitors or inducers, P-glycoprotein (P-gp) inhibitors, or drugs that suppress gastric acid production (e.g., proton pump inhibitors, PPIs) within 28 days prior to the first dose (refer to Table 3 for CYP3A4 and P-gp inhibitors\u002Finducers and PPI inhibitors).\n  14. Use of prescription drugs, over-the-counter medications, dietary supplements, or herbal medicines within 14 days prior to the first dose.\n  15. Consumption of chocolate, any food or beverage containing caffeine or xanthine, grapefruit, or grapefruit-related citrus fruits (e.g., pomelo) or juices within 48 hours prior to dosing in each cycle.\n  16. Positive screening result for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody; or history of active or latent tuberculosis (TB).\n  17. History of any QT interval prolongation (including from previous studies) or known risk factors (e.g., hypokalemia, hypomagnesemia, or recent use of drugs known to prolong QTcF); or during screening, a resting 12-lead electrocardiogram (ECG) showing a corrected QTcF \\>450 ms, PR interval \\>210 ms, or QRS complex \\>120 ms; or resting heart rate ≤60 bpm.\n  18. Ophthalmological examination abnormalities at screening, other than refractive errors, deemed clinically significant by the investigator.\n  19. Vaccination within 4 weeks prior to screening.\n  20. Unwillingness or inability to comply with the lifestyle guidelines described in the study protocol (e.g., dietary restrictions, activity, and contraceptive requirements).\n  21. Any other factors considered by the investigator as unsuitable for participation in this trial.",true,"ALL","18 Years","50 Years",{"count":71,"type":72},18,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","A Phase I, Single-Center, Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Effect of High-Fat and Low-Fat Meals on the Pharmacokinetics of FWD1802 in Chinese Healthy Subjects. The primary objectives are to address the following questions:\n\nTo evaluate the impact of high-fat and low-fat meals on the pharmacokinetic (PK) characteristics of a single oral dose of FWD1802 in healthy Chinese Subjects.",[78],"Healthy","NOT_YET_RECRUITING","2026-03-12",{"date":82,"type":83},"2026-03-17","ACTUAL",{"date":85,"type":72},"2026-03",{"date":87,"type":72},"2026-08",{"name":5,"class":6},1]