Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects (NCT07476963) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects
China18 participantsStarted 2026-03
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 range18 Years – 50 Years
SexALL
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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.
✓. 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.
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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-∞)
. 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).