Safety and Food Effect on Single-Dose Bioavailability of F-02-2-Na in Healthy Adult Subjects

NCT07346027 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: F-02-2-Na-2025-PROT-I-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to evaluate the impact of food on the pharmacokinetics of F-02-2-Na in healthy adult subjects by observing the changes in the drug's pharmacokinetic profile-particularly in its absorption process-before and after food intake.

Conditions

Hyperuricemia With or Without Gout

Outcome Measures

Primary Outcomes (10)

• 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.

  From pre-dose (baseline) to 72 hours after the last dose.

• Proportion of subjects with abnormal urinalysis findings following single orally administered doses of F-02-2-Na

  Proportion of healthy adult subjects with clinically significant abnormalities in urinalysis parameters (e.g., protein, glucose, blood, microscopic examination) 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 clinical chemistry findings following single orally administered doses of F-02-2-Na

  Proportion of healthy adult subjects with clinically significant abnormalities in clinical chemistry parameters (e.g., sodium, potassium, chloride, calcium, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, BUN, glucose) 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 renal morphology following single orally administered doses of F-02-2-Na

  Proportion of healthy adult subjects with abnormal renal morphology as assessed by Renal Color Doppler Ultrasonography (Renal CDU) following single orally administered doses of F-02-2-Na.

  From pre-dose (baseline) to 72 hours post dose

• Proportion of subjects with abnormal pelvicalyceal system findings following single orally administered doses of F-02-2-Na

  Proportion of healthy adult subjects with abnormal pelvicalyceal system findings as assessed by Renal Color Doppler Ultrasonography (Renal CDU) following single orally administered doses of F-02-2-Na.

  From pre-dose (baseline) to 72 hours post dose

• Proportion of subjects with abnormal renal vascular hemodynamics following single orally administered doses of F-02-2-Na

  Proportion of healthy adult subjects with abnormal renal vascular hemodynamics as assessed by Renal CDU following single orally administered doses of F-02-2-Na.

  From pre-dose (baseline) to 72 hours post dose

Secondary Outcomes (11)

• The effect of food on the pharmacokinetic Profile (Cmax) of F-02-2-Na in healthy adult subjects

  From pre-dose (baseline) to 72 hours post dose

• The effect of food on the Pharmacokinetic Profile: Area Under the Concentration (AUC0-t) of F-02-2-Na in healthy Adult Subjects

  From pre-dose (baseline) to 72 hours post dose

• The effect of food on the Pharmacokinetic Profile: Area Under the Concentration (AUC0-∞) of F-02-2-Na in healthy Adult Subjects

  From pre-dose (baseline) to 72 hours post dose

• The effect of food on the Pharmacokinetic Profile: Time to Maximum Plasma Concentration (Tmax) of F-02-2-Na in healthy Adult Subjects

  From pre-dose (baseline) to 72 hours post dose

• The effect of food on the Pharmacokinetic Profile: Terminal Elimination Half-Life (t1/2) of F-02-2-Na in Adult Subjects

  From pre-dose (baseline) to 72 hours post dose

Study Arms (2)

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)

Interventions

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).

Also known as: FE-1 Fasting-Fed Group

FE-1 Fasting-Fed Group

Fed administration of F-02-2-Na (50mg) - Fasting administration of F-02-2-Na (50mg) DRUG

Firstly, subjects will receive a fed 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 fasting administration of F-02-2-Na (50 mg).

Also known as: FE-2 Fed-Fasting Group

FE-2 Fed-Fasting Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. 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.
• \. Healthy male or female subjects aged 18 to 45 years old (inclusive).
• \. 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).
• \. 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.
• \. Normal renal function as determined by Investigator following review of clinical laboratory test results, including eGFR ≥ 90 mL/min/1.73 m².
• \. 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.
• \. The subjects should be able to communicate well with the researchers and understand and comply with the requirements of this study.

You may not qualify if:

• \. 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).
• \. Subjects who have had an acute illness within two weeks before the first drug administration (ascertained through inquiry).
• \. 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).
• \. Subjects with a history of gastrointestinal, liver, kidney, and thyroid diseases that can affect drug absorption or metabolism (ascertained through inquiry).
• \. Subjects with a history of gout (ascertained through inquiry).
• \. 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).
• \. Subjects who have used any mercaptopurine hydrate or thiopurine drugs within four weeks before the study (ascertained through inquiry).
• \. 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)
• \. 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).
• \. Subjects who have received vaccination within three months before the study (ascertained through inquiry).
• \. 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).
• \. 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).
• \. 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).
• \. 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).
• \. 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).

Sponsors & Collaborators

• Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.: lead
• Xiangbei Welman Pharmaceutical Co., Ltd: collaborator
• Guangzhou Xin-Chuangyi Biopharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (4)

• 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.

  PMID: 35106590 BACKGROUND

• Ding R, Chen L, Li X, Xiong T, Chen H, Hu X, Li Y, Zhou Y, Liu K, Wu J, Jiang F, Peng Q. A Phase I Study to Evaluate the Pharmacokinetic Drug-Drug Interaction of HP501, Febuxostat, and Colchicine in Male Chinese Patients with Hyperuricemia. Clin Drug Investig. 2023 Jun;43(6):401-411. doi: 10.1007/s40261-023-01274-7. Epub 2023 May 30.

  PMID: 37248357 BACKGROUND

• Hall J, Gillen M, Yang X, Shen Z. Pharmacokinetics, Pharmacodynamics, and Tolerability of Concomitant Administration of Verinurad and Febuxostat in Healthy Male Volunteers. Clin Pharmacol Drug Dev. 2019 Feb;8(2):179-187. doi: 10.1002/cpdd.463. Epub 2018 Apr 24.

  PMID: 29688628 BACKGROUND

• Lee HA, Yu KS, Park SI, Yoon S, Onohara M, Ahn Y, Lee H. URC102, a potent and selective inhibitor of hURAT1, reduced serum uric acid in healthy volunteers. Rheumatology (Oxford). 2019 Nov 1;58(11):1976-1984. doi: 10.1093/rheumatology/kez140.

  PMID: 31056705 BACKGROUND

Study Officials

• 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

Central Study Contacts

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

CONTACT

(+)86 13926018606; 13926018606@139.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: January 16, 2026
• Study Start: February 1, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)