Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects (NCT07476963) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects
China18 participantsStarted 2026-03-15
Plain-language summary
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:
To 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Chinese male or female subjects, aged 18-45 years (inclusive) for males and 18-50 years (inclusive) for females at the time of screening.
. Body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak Plasma Concentration (Cmax)
Timeframe: 240 hours
2
Area under the plasma concentration versus time curve (AUC0-t)
Timeframe: 240 hours
3
Area under the plasma concentration versus time curve (AUC0-∞)
. 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 / 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.
Exclusion criteria
. 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.
. History of severe allergies (including allergic constitution, drug allergies, allergies to two or more types of food, etc.) or known hypersensitivity to FWD1802 and/or any of its excipients.
. 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.
. History of dysphagia or any gastrointestinal disease that may affect drug absorption (including but not limited to gastrointestinal dysfunction, total/partial gastrectomy, gastrointestinal bleeding/ulcer, malabsorption syndrome, uncontrolled nausea/vomiting/diarrhea, etc.).
. Undergone surgery within 3 months prior to screening or planned surgery during the study period.
. Intolerance to venipuncture, history of needle phobia/blood phobia, or difficulty with blood collection.
. History of drug abuse or positive urine drug abuse screening (at baseline).
. 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).