Safety and Food Effect on Single-Dose Bioavailability of... | NCT07346027

Name	Class
Xiangbei Welman Pharmaceutical Co., Ltd	INDUSTRY
Guangzhou Xin-Chuangyi Biopharmaceutical Co., Ltd.	UNKNOWN

Label	Type	Description	Intervention Names
FE-1 Fasting-Fed Group	Experimental	Fasting administration of F-02-2-Na - Fed administration of F-02-2-Na	Drug: Fasting administration of F-02-2-Na (50mg) - Fed administration of F-02-2-Na (50mg)
FE-2 Fed-Fasting Group	Experimental	Fed administration of F-02-2-Na - Fasting administration of F-02-2-Na	Drug: Fed administration of F-02-2-Na (50mg) - Fasting administration of F-02-2-Na (50mg)

Name	Type	Description	Arm Group Labels	Other Names
Fasting administration of F-02-2-Na (50mg) - Fed administration of F-02-2-Na (50mg)	Drug	Firstly, subjects will receive a fasting administration of F-02-2-Na (50 mg); secondly, a washout period of at least 4 days will be implemented; thirdly, subjects will receive a fed administration of F-02-2-Na (50 mg).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety Assessment: Adverse Events (AEs) of single orally administered doses of F-02-2-Na in healthy adult subjects	Incidence, severity, and seriousness of adverse events (AEs) of single orally administered doses of F-02-2-Na in healthy adult subjects.	From the start of the first dose to 72 hours after the last dose.
Safety Assessment: Proportion of subjects using Concomitant Medications during single orally administered doses of F-02-2-Na	Proportion of healthy adult Subjects Using Concomitant Medications during treatment with single orally administered doses of F-02-2-Na.	From the start of the first dose to 72 hours after the last dose.
Safety Assessment: Proportion of subjects with Electrocardiogram (ECG) Findings following single orally administered doses of F-02-2-Na	Proportion of healthy adult subjects with abnormal findings in electrocardiogram (ECG) parameters (including PR interval, QRS duration, QT/QTc interval, heart rate, and rhythm) following single orally administered doses of F-02-2-Na.	From pre-dose (baseline) to 72 hours after the last dose.
Proportion of subjects with abnormal hematology findings following single orally administered doses of F-02-2-Na	Proportion of healthy adult subjects with clinically significant abnormalities in hematology parameters (e.g., hemoglobin, hematocrit, red blood cell count, white blood cell count with differential, platelet count) following single orally administered doses of F-02-2-Na.	From pre-dose (baseline) to 72 hours after the last dose.
Proportion of healthy subjects with abnormal coagulation findings following single orally administered doses of F-02-2-Na	Proportion of healthy adult subjects with clinically significant abnormalities in coagulation parameters (e.g., PT, INR, aPTT) following F-02-2-Na.

Secondary Outcomes

Measure	Description	Time Frame
The effect of food on the pharmacokinetic Profile (Cmax) of F-02-2-Na in healthy adult subjects	To determine whether food intake affects key pharmacokinetic parameters: Cmax (maximum plasma concentration) of F-02-2-Na following single oral doses in healthy adult subjects.	From pre-dose (baseline) to 72 hours post dose

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. The subjects should fully understand the purpose, nature, process of the study and the possible adverse reactions, voluntarily act as subjects, and sign the informed consent form before the start of any research procedures.
2. Healthy male or female subjects aged 18 to 45 years old (inclusive).
3. The body weight for male and female subjects should be ≥ 50.0 kg and ≥ 45.0 kg, respectively; the body mass index (BMI) should be between 19 kg/m² and 26 kg/m² (inclusive).
4. The subjects should have normal results or abnormal results without clinical significance in vital signs check, physical examination, clinical laboratory tests (Complete Blood Count (CBC), urine analysis, blood biochemistry, coagulation panel, free thyroid function tests), chest X-ray, liver and renal color ultrasound and 12-lead electrocardiogram.
5. Normal renal function as determined by Investigator following review of clinical laboratory test results, including eGFR ≥ 90 mL/min/1.73 m².
6. The subjects (including male subjects) should have no plans for having children from screening until 6 months after the last dose and should voluntarily take effective contraceptive measures and have no plans for sperm or egg donation.
7. The subjects should be able to communicate well with the researchers and understand and comply with the requirements of this study.

Exclusion Criteria:

1. Subjects with a specific allergic history (such as asthma, urticaria, eczema, etc.) or those with an allergic constitution (such as those known to be allergic to two or more substances), or those with a known history of allergy to F-02-2-Na and related excipients (ascertained through inquiry).
2. Subjects who have had an acute illness within two weeks before the first drug administration (ascertained through inquiry).
3. Subjects with diseases of important organs or systems (including but not limited to liver, kidney, nervous system, blood, endocrine system, lungs, immune system, mental health, cardiovascular and cerebrovascular system, gastrointestinal tract, skin, metabolism, bone and joints, etc.) that are considered clinically significant by the researcher, or those with a history of such serious diseases; or those with a history of tumor (ascertained through inquiry).
4. Subjects with a history of gastrointestinal, liver, kidney, and thyroid diseases that can affect drug absorption or metabolism (ascertained through inquiry).
5. Subjects with a history of gout (ascertained through inquiry).
6. Subjects who have used any medications (including any prescription drugs, over-the-counter drugs, traditional Chinese herbal medicines) and health products within two weeks before the first drug administration (ascertained through inquiry).
7. Subjects who have used any mercaptopurine hydrate or thiopurine drugs within four weeks before the study (ascertained through inquiry).
8. Subjects who have heavily consumed, within 2 weeks prior to the first dose, or ingested within 48 hours prior to dosing, beverages containing caffeine or alcohol, or foods known to affect drug metabolism (such as chocolate, pitaya, mango, pomelo, carambola, guava, orange, grapefruit, or grapefruit products). (ascertained through inquiry)
9. Subjects who have undergone major surgical procedures (excluding diagnostic surgical procedures) within six months before the study , or those who plan to have surgery during the research period, or those who have undergone surgeries that, in the judgment of the researcher, can affect drug absorption, distribution, metabolism, and excretion (ascertained through inquiry).
10. Subjects who have received vaccination within three months before the study (ascertained through inquiry).
11. Subjects who have participated in any other clinical trial within 3 months prior to the current study. (Note: The end date is defined as the date of completion/exit from the previous clinical trial.) (ascertained through inquiry).
12. Subjects who have donated blood within three months before the study, or those whose total blood loss due to blood donation or other reasons has reached or exceeded 400 mL within six months (ascertained through inquiry).
13. Subjects who, on average, consumed more than 14 units of alcohol per week over the past year, or those unable to abstain from alcohol during the study period, or individuals with a breath alcohol test result greater than 0.0 mg/100 mL (ascertained through inquiry/examination).
14. Subjects who smoke more than 5 cigarettes per day on average within three months before the study, or those who cannot stop using any tobacco products during the study (ascertained through inquiry).
15. Subjects with a history of drug abuse (including the repeated and excessive use of various narcotic drugs and psychotropic substances for non-medical purposes) or positive results in drug abuse screening (including morphine, methamphetamine, ketamine, MDMA (3,4-methylenedioxymethamphetamine), cannabis (tetrahydrocannabinolic acid), etc.) within the past year (ascertained through inquiry and examination).
16. Subjects with a positive result in any item of the infectious disease examination during the screening period (including hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, and treponema pallidum antibody) (examination).
17. Subjects who cannot tolerate venipuncture/indwelling needle or those with a history of fainting at the sight of needles or blood (ascertained through inquiry).
18. Subjects with difficult venous blood collection (ascertained through inquiry).
19. Subjects with lactose intolerance (ascertained through inquiry). 20. Subjects with special dietary requirements and who cannot accept the unified diet (ascertained through inquiry).
21. Subjects with dysphagia (ascertained through inquiry).
22. Other subjects are deemed unsuitable for participation by the researcher.
23. In addition to the above requirements, female subjects who meet the following conditions should also be excluded:
a. Those who have used oral contraceptives within 30 days before the study (ascertained through inquiry).
b. Those who have used long-acting estrogen or progesterone injections (including progesterone-containing intrauterine contraceptive devices) or implanted tablets within 6 months before the study (ascertained through inquiry).
c. Those who have unprotected sexual intercourse with their partners within 14 days before the study (ascertained through inquiry).
d. Those with a positive blood pregnancy test result (examination).
e. Pregnant or lactating women (ascertained through inquiry).

Name	Affiliation	Role
Junyan Wu, MS	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Principal Investigator
Donghui Zheng, MM	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Principal Investigator

PubMed Identifier	Type	Citation	Retractions
35106590	Background	Wang Z, Li X, Jin Y, Liu R, Di X, Zhou Y, Wang Y, Fan L, Chen Y, Wang Y, Zheng L. Safety, Efficacy, and Pharmacokinetics of HP501 in Healthy Volunteers and Hyperuricemic Patients: A Phase I/IIa Study. J Clin Endocrinol Metab. 2022 May 17;107(6):1667-1678. doi: 10.1210/clinem/dgac032.
37248357	Background