HealthyPhase 1NCT07476963
Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects
A Phase 1 study testing FWD1802 in people with Healthy, run by Forward Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- FWD1802
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to Sep 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- 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.
Who cannot join
- Subjects who meet any of the following exclusion criteria will not be eligible for enrollment in this study:
- 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.
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- 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).
- Smoking history of more than 10 cigarettes per day within 3 months prior to screening.
- Excessive consumption of tea, coffee, and/or caffeine-rich beverages (average >8 cups per day, 1 cup = 250 mL) within 3 months prior to screening.
- Donated blood or experienced significant blood loss (≥400 mL), or received blood transfusion or blood products within 3 months prior to the first dose.
- 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.
- Use of any moderate/strong 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/inducers and PPI inhibitors).
- Use of prescription drugs, over-the-counter medications, dietary supplements, or herbal medicines within 14 days prior to the first dose.
- 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.
- 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).
- 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.
- Ophthalmological examination abnormalities at screening, other than refractive errors, deemed clinically significant by the investigator.
- Vaccination within 4 weeks prior to screening.
- Unwillingness or inability to comply with the lifestyle guidelines described in the study protocol (e.g., dietary restrictions, activity, and contraceptive requirements).
- Any other factors considered by the investigator as unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Xuhui Central Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: 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
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.
Read the detailed description
A Phase I, single-center, open-label, randomized, single-dose, three-period crossover study conducted in Chinese healthy subjects to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of FWD1802.
A total of 18 healthy subjects are planned to be enrolled. Subjects will be randomly assigned in a 1:1:1 ratio to one of three sequences. Each sequence consists of three cycles, with one dose administered per cycle, and a washout period of ≥14 days between consecutive doses. The three sequences are as follows:
Sequence 1: Cycle 1 - administration under fasting conditions; Cycle 2 - administration after a low-fat meal; Cycle 3 - administration after a high-fat meal.
Sequence 2: Cycle 1 - administration after a low-fat meal; Cycle 2 - administration after a high-fat meal; Cycle 3 - administration under fasting conditions.
Sequence 3: Cycle1 - administration after a high-fat meal; Cycle 2 - administration under fasting conditions; Cycle 3 - administration after a low-fat meal.
Notes:
- Fasting Condition (Reference): A single dose of 150 mg FWD1802 is taken orally after fasting for at least 10 hours (water is allowed as needed).
- Low-Fat Meal: A single dose of 150 mg FWD1802 is taken orally after a low-fat meal.
- High-Fat Meal: A single dose of 150 mg FWD1802 is taken orally after a high-fat meal.
- Low-Fat Meal: Total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content.
- High-Fat Meal: A high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), with approximately 150, 250, and 500-600 Kcal derived from protein, carbohydrates, and fat, respectively. The composition of the high-fat and low-fat meals must be consistent across all cycles.
- Conditions
- Healthy
- Being tested
- FWD1802
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FWD1802Drug
Single-dose of 150 mg of FWD1802.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: FWD1802 |
| Sequence 2 | Experimental | 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. Receives: Drug: FWD1802 |
| Sequence 3 | Experimental | 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. Receives: Drug: FWD1802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration (Cmax) of FWD1802
Measured: 240 hours
Area under the plasma concentration versus time curve (AUC0-t)
Area under the plasma concentration versus time curve (AUC) from time zero to the last quantifiable time point of FWD1802
Measured: 240 hours
Area under the plasma concentration versus time curve (AUC0-∞)
Area under the plasma concentration versus time curve from time zero extrapolated to infinity of FWD1802
Measured: 240 hours
Secondary outcomes (11)
Time to Peak Concentration (Tmax)
Time to Peak Concentration (Tmax) of FWD1802
Measured: 240 hours
Percentage of the area under the plasma concentration-time curve from time 0 extrapolated to infinity
Percentage of the area under the plasma concentration-time curve from time 0 extrapolated to infinity of FWD1802
Measured: 240 hours
Absorption lag time (t lag)
Absorption lag time (t lag) of FWD1802
Measured: 240 hours
Half-life (t₁/₂)
Half-life (t₁/₂) of FWD1802
Measured: 240 hours
Apparent clearance (CL/F)
Apparent clearance (CL/F) of FWD1802
Measured: 240 hours
Apparent volume of distribution (Vz/F)
Apparent volume of distribution (Vz/F) of FWD1802
Measured: 240 hours
Elimination rate constant (Kel)
Elimination rate constant (Kel) of FWD1802
Measured: 240 hours
Mean residence time (MRT)
Mean residence time (MRT) of FWD1802
Measured: 240 hours
Inter-individual variability
Interindividual variability in the primary PK parameters AUC₀-ₜ, AUC₀-∞, and Cmax following administration of FWD1802
Measured: 240 hours
Intraindividual variability
Intraindividual variability in the primary PK parameters AUC₀-ₜ, AUC₀-∞, and Cmax of FWD1802
Measured: 240 hours
Monitoring and Recording of AE and Laboratory Tests in Subjects.
Number of Participants with Adverse Events (AEs), Abnormal Safety Laboratory Findings, Abnormal Vital Signs, and Abnormal 12-Lead Electrocardiogram (ECG) Results
Measured: 240 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start15 Mar 2026
- Primary completion6 Jul 2026
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forward Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanmei Liu, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476963
- Sponsor's protocol ID
- FWD1802-FE
- Status last verified
- Feb 2026
- First submitted
- 28 Feb 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07476963
- Acronym / sponsor ID
- FWD1802-FE
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Forward Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2026 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A Phase I, single-center, open-label, randomized, single-dose, three-period crossover study conducted in Chinese healthy subjects to evaluate the effect of high-fat and low-fat meals on the pharmacokinetics of FWD1802.
A total of 18 healthy subjects are planned to be enrolled. Subjects will be randomly assigned in a 1:1:1 ratio to one of three sequences. Each sequence consists of three cycles, with one dose administered per cycle, and a washout period of ≥14 days between consecutive doses. The three sequences are as follows:
Sequence 1: Cycle 1 - administration under fasting conditions; Cycle 2 - administration after a low-fat meal; Cycle 3 - administration after a high-fat meal.
Sequence 2: Cycle 1 - administration after a low-fat meal; Cycle 2 - administration after a high-fat meal; Cycle 3 - administration under fasting conditions.
Sequence 3: Cycle1 - administration after a high-fat meal; Cycle 2 - administration under fasting conditions; Cycle 3 - administration after a low-fat meal.
Notes:
- Fasting Condition (Reference): A single dose of 150 mg FWD1802 is taken orally after fasting for at least 10 hours (water is allowed as needed).
- Low-Fat Meal: A single dose of 150 mg FWD1802 is taken orally after a low-fat meal.
- High-Fat Meal: A single dose of 150 mg FWD1802 is taken orally after a high-fat meal.
- Low-Fat Meal: Total calories approximately 400-500 Kcal, with fat constituting approximately 25% of the total caloric content.
- High-Fat Meal: A high-calorie (approximately 800-1000 Kcal) and high-fat meal (fat constituting approximately 50% of the total caloric content), with approximately 150, 250, and 500-600 Kcal derived from protein, carbohydrates, and fat, respectively. The composition of the high-fat and low-fat meals must be consistent across all cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: FWD1802Enrolled 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. |
| Sequence 2 | Experimental | Drug: FWD1802Enrolled 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. |
| Sequence 3 | Experimental | Drug: FWD1802Enrolled 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:
Key exclusion criteria (22 listed)
- Subjects who meet any of the following exclusion criteria will not be eligible for enrollment in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FWD1802Single-dose of 150 mg of FWD1802. | Drug | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 240 hours
Peak Plasma Concentration (Cmax) of FWD1802
Area under the plasma concentration versus time curve (AUC0-t)
Time frame: 240 hours
Area under the plasma concentration versus time curve (AUC) from time zero to the last quantifiable time point of FWD1802
Area under the plasma concentration versus time curve (AUC0-∞)
Time frame: 240 hours
Area under the plasma concentration versus time curve from time zero extrapolated to infinity of FWD1802
11 secondary outcomes
Time to Peak Concentration (Tmax)
Time frame: 240 hours
Percentage of the area under the plasma concentration-time curve from time 0 extrapolated to infinity
Time frame: 240 hours
Absorption lag time (t lag)
Time frame: 240 hours
Half-life (t₁/₂)
Time frame: 240 hours
Apparent clearance (CL/F)
Time frame: 240 hours
Apparent volume of distribution (Vz/F)
Time frame: 240 hours
Elimination rate constant (Kel)
Time frame: 240 hours
Mean residence time (MRT)
Time frame: 240 hours
Inter-individual variability
Time frame: 240 hours
Intraindividual variability
Time frame: 240 hours
Monitoring and Recording of AE and Laboratory Tests in Subjects.
Time frame: 240 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanmei Liu principal investigator
Xuhui Central Hospital, Shanghai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FWD1802 in people with Healthy, run by Forward Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 240 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.