A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects

NCT07324434 | Enrolling By Invitation Phase 1 FDA Drug

• 1 other identifier: F-02-2-Na-2025-PROT-I-1
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of ascending single orally administered doses of F-02-2-Na in adult subjects (to include the Mass Balance) \& multiple orally administered doses of F-02-2-Na in adult subjects with Hyperuricemia.

Conditions

Hyperuricemia With or Without Gout

Outcome Measures

Primary Outcomes (28)

• Safety and tolerability: Adverse Events (AEs) of ascending single and multiple oral doses of F-02-2-Na in adult subjects.

  Incidence, severity, and seriousness of adverse events (AEs) following ascending single and multiple oral doses of F-02-2-Na in adult subjects.

  0-72 hours post dose

• Safety and Tolerability: Concomitant Medications of ascending single and multiple oral doses in Adult Subjects

  Proportion of adult Subjects Using Concomitant Medications During Treatment during treatment with ascending single and multiple oral doses of F-02-2-Na.

  0-72 hours post dose

• Safety and Tolerability: Electrocardiogram (ECG) Findings ascending single and multiple oral doses of F-02-2-Na in Adult Subjects

  Proportion of adult subjects with abnormal findings in electrocardiogram (ECG) parameters (including PR interval, QRS duration, QT/QTc interval, heart rate, and rhythm) following ascending single and multiple oral 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 ascending single and multiple oral doses of F-02-2-Na.

  Proportion of subjects with clinically significant abnormalities in hematology parameters (e.g., hemoglobin, hematocrit, red blood cell count, white blood cell count with differential, platelet count).

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

• Proportion of subjects with abnormal coagulation findings following ascending single and multiple oral doses of F-02-2-Na.

  Proportion of adult subjects with clinically significant abnormalities in coagulation parameters (e.g., PT, INR, aPTT).

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

• Proportion of subjects with abnormal urinalysis findings following ascending single and multiple oral doses of F-02-2-Na.

  Proportion of adult subjects with clinically significant abnormalities in urinalysis parameters (e.g., protein, glucose, blood, microscopic examination)

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

• Proportion of subjects with abnormal clinical chemistry findings following ascending single and multiple oral doses of F-02-2-Na

  Incidence of clinically significant abnormalities in clinical chemistry parameters (e.g., sodium, potassium, chloride, calcium, ALT, AST, total bilirubin, alkaline phosphatase, creatinine, BUN, glucose).

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

• Proportion of subjects with abnormal renal morphology following administration of F-02-2-Na

  Proportion of adult subjects with abnormal renal morphology as assessed by Renal Color Doppler Ultrasonography (Renal CDU) following ascending single and multiple oral doses of F-02-2-Na

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

• Proportion of subjects with abnormal pelvicalyceal system findings following administration of F-02-2-Na

  Proportion of adult subjects with abnormal pelvicalyceal system findings as assessed by Renal CDU following ascending single and multiple oral doses of F-02-2-Na.

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

• Proportion of subjects with abnormal renal vascular hemodynamics following administration of F-02-2-Na

  Proportion of adult subjects with abnormal renal vascular hemodynamics as assessed by Renal CDU following ascending single and multiple oral doses of F-02-2-Na.

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

• Pharmacokinetic Profile: Maximum Plasma Concentration (Cmax) of F-02-2-Na in healthy Adult Subjects

  To evaluate the Pharmacokinetic parameters:Maximum plasma concentration (Cmax) of F-02-2-Na following ascending single oral doses in healthy adult subjects.

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

• Area Under the Concentration (AUC0-t) of F-02-2-Na in healthy Adult Subjects

  To evaluate the Pharmacokinetic parameters:Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) of F-02-2-Na following ascending single oral doses in healthy adult subjects.

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

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

  To evaluate the Pharmacokinetic parameters: Area Under the Concentration-Time Curve from Time 0 to Extrapolated Infinity (AUC0-∞) of F-02-2-Na following ascending single oral doses in healthy adult subjects.

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

• Pharmacokinetic Profile: Time to Maximum Plasma Concentration (Tmax) of F-02-2-Na in Adult Subjects

  To evaluate the Pharmacokinetic parameters:Time to reach maximum plasma concentration (Tmax) of F-02-2-Na following ascending single and multiple oral doses in adult subjects.

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

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

  To evaluate the Pharmacokinetic Parameters:Terminal elimination half-life (t1/2) of F-02-2-Na following ascending single and multiple oral doses in adult subjects.

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

• Pharmacokinetic Profile: Mean Residence Time from Time 0 to Last Quantifiable Concentration (MRT0-t) of F-02-2-Na in Healthy Adult Subjects

  To evaluate the pharmacokinetic parameters:Mean residence time from time 0 to the last quantifiable concentration (MRT0-t) of F-02-2-Na following ascending single oral doses in healthy adult subjects.

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

• Pharmacokinetic Profile: Mean Residence Time from Time 0 to Extrapolated Infinity (MRT0-∞) of F-02-2-Na in Adult Subjects

  To evaluate the pharmacokinetic parameters: Mean residence time from time 0 to extrapolated infinity (MRT0-∞) of F-02-2-Na following ascending single and multiple oral doses in adult subjects.

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

• Pharmacokinetic Profile: Apparent Clearance/Bioavailability (CL/F) of F-02-2-Na in Adult Subjects

  To evaluate the pharmacokinetic parameters: Apparent clearance normalized to bioavailability (CL/F) of F-02-2-Na following ascending single and multiple oral doses in adult subjects.

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

• Pharmacokinetic Profile: Apparent Volume of Distribution at Steady State (Vz/F) of F-02-2-Na in Adult Subjects

  To evaluate the pharmacokinetic parameters: Apparent volume of distribution at steady state (Vz/F) of F-02-2-Na following ascending single and multiple oral doses in adult subjects.

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

• Pharmacokinetic Profile: Terminal Elimination Rate Constant (Kel) of F-02-2-Na in Healthy Adult Subjects

  To evaluate the pharmacokinetic parameters: Terminal elimination rate constant (Kel) of F-02-2-Na following ascending single oral doses in healthy adult subjects.

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

• Pharmacokinetic Profile: Minimum Steady-State Plasma Concentration (Css_min) of F-02-2-Na in Adult Subjects with Hyperuricemia

  To evaluate the pharmacokinetic parameters: Minimum Steady-State Plasma Concentration (Css\_min) of F-02-2-Na following ascending multiple oral doses in Adult Subjects with Hyperuricemia.

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

• Pharmacokinetic Profile: Maximum Steady-State Plasma Concentration (Css_max) of F-02-2-Na in Adult Subjects with Hyperuricemia

  To evaluate the pharmacokinetic parameters: Maximum Steady-State Plasma Concentration (Css\_max) of F-02-2-Na following ascending multiple oral doses in Adult Subjects with Hyperuricemia.

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

• Pharmacokinetic Profile: Average Steady-State Plasma Concentration (Css_av) of F-02-2-Na in Adult Subjects with Hyperuricemia

  To evaluate the pharmacokinetic parameters: Average Steady-State Plasma Concentration (Css\_av) of F-02-2-Na following ascending multiple oral doses in Adult Subjects with Hyperuricemia.

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

• Pharmacokinetic Profile: Area Under the Concentration (AUCss,0-t) of F-02-2-Na in Adult Subjects with Hyperuricemia

  To evaluate the pharmacokinetic parameters: Area Under the Steady-State Concentration-Time Curve from Time 0 to Last Quantifiable Concentration (AUCss,0-t) of F-02-2-Na following ascending multiple oral doses in Adult Subjects with Hyperuricemia.

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

• Pharmacokinetic Profile: Area Under the Concentration (AUCss,0-∞) of F-02-2-Na in Adult Subjects with Hyperuricemia

  To evaluate the pharmacokinetic parameters: Area Under the Steady-State Concentration-Time Curve from Time 0 to Extrapolated Infinity(AUCss,0-∞) of F-02-2-Na following ascending multiple oral doses in Adult Subjects with Hyperuricemia.

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

• Pharmacokinetic Profile: Area Under the Concentration (AUC0-tau) of F-02-2-Na in Adult Subjects with Hyperuricemia

  To evaluate the pharmacokinetic parameters: Area Under the Concentration-Time Curve over One Dosing Interval (AUC0-tau) of F-02-2-Na following ascending multiple oral doses in Adult Subjects with Hyperuricemia.

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

• Pharmacokinetic Profile: Accumulation Ratio (Rac) of F-02-2-Na in Adult Subjects with Hyperuricemia

  To evaluate the pharmacokinetic parameters: Accumulation Ratio (Rac) of F-02-2-Na following ascending multiple oral doses in Adult Subjects with Hyperuricemia.

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

• Pharmacokinetic Profile: Degree of Fluctuation (DF) of F-02-2-Na in Adult Subjects with Hyperuricemia

  To evaluate the pharmacokinetic parameters: Degree of Fluctuation (DF) of F-02-2-Na following ascending multiple oral doses in Adult Subjects with Hyperuricemia.

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

Secondary Outcomes (11)

• Mass Balance: Total Renal Excretion Amount of F-02-2-Na in Healthy Adult Subjects

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

• Mass Balance: Fecal Excretion Rate of F-02-2-Na in Healthy Adult Subjects

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

• Mass Balance: Total Fecal Excretion Amount of F-02-2-Na in Healthy Adult Subjects

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

• Explore the dose-exposure-effect relationship：Correlation between Exposure Parameters of F-02-2-Na and Serum Uric Acid (sUA) Reduction in Adult Subjects

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

• Exploration of Potential Biomarkers Associated with the Pharmacodynamics of F-02-2-Na in Adult Subjects

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

Study Arms (18)

A1-0.5mg T

EXPERIMENTAL

The intervention consists of a single oral administration of F-02-2-Na (0.5 mg). The study drug is administered in a fasting state (at least 10 hours), and subjects will be continuously monitored for 72 hours following administration in Safety and PKPD assessments.

Drug: F-02-2-Na Tablet (0.5 mg)

A1-0.5mg R

PLACEBO COMPARATOR

The intervention consists of a single oral administration of matching placebo (0.5mg). The administration conditions are the same as those for the experimental arm

Drug: F-02-2-Na Matching Placebo (0.5mg)

A2-5mg-T

EXPERIMENTAL

The intervention consists of a single oral administration of F-02-2-Na (5 mg). The study drug is administered in a fasting state (at least 10 hours), and subjects will be continuously monitored for 72 hours following administration in Safety and PKPD assessments

Drug: F-02-2-Na Tablet (5mg)

A2-5mg-R

PLACEBO COMPARATOR

The intervention consists of a single oral administration of matching placebo (5mg). The administration conditions are the same as those for the experimental arm.

Drug: F-02-2-Na Matching Placebo (5mg)

A3-25mg-T

EXPERIMENTAL

The intervention consists of a single oral administration of F-02-2-Na (25 mg). The study drug is administered in a fasting state (at least 10 hours), and subjects will be continuously monitored for 72 hours following administration in Safety and PKPD assessments.

Drug: F-02-2-Na Tablet (25mg)

A3-25mg-R

PLACEBO COMPARATOR

The intervention consists of a single oral administration of matching placebo (25mg). The administration conditions are the same as those for the experimental arm.

Drug: F-02-2-Na Matching Placebo (25mg)

A4-75mg-T

EXPERIMENTAL

The intervention consists of a single oral administration of F-02-2-Na (75 mg). The study drug is administered in a fasting state (at least 10 hours), and subjects will be continuously monitored for 72 hours following administration in Safety and PKPD assessments.

Drug: F-02-2-Na Tablet (75mg)

A4-75mg-R

PLACEBO COMPARATOR

The intervention consists of a single oral administration of matching placebo (75mg). The administration conditions are the same as those for the experimental arm.

Drug: F-02-2-Na Matching Placebo (75mg)

A5-150mg-T

EXPERIMENTAL

The intervention consists of a single oral administration of F-02-2-Na (150 mg). The study drug is administered in a fasting state (at least 10 hours), and subjects will be continuously monitored for 72 hours following administration in Safety and PKPD assessments

Drug: F-02-2-Na Tablet (150 mg)

A5-150mg-R

PLACEBO COMPARATOR

The intervention consists of a single oral administration of matching placebo (150mg). The administration conditions are the same as those for the experimental arm.

Drug: F-02-2-Na Matching Placebo (150 mg)

A6-200mg-T

EXPERIMENTAL

The intervention consists of a single oral administration of F-02-2-Na (200 mg). The study drug is administered in a fasting state (at least 10 hours), and subjects will be continuously monitored for 72 hours following administration in Safety and PKPD assessments.

Drug: F-02-2-Na Tablet (200 mg)

A6-200mg-R

PLACEBO COMPARATOR

The intervention consists of a single oral administration of matching placebo (200mg). The administration conditions are the same as those for the experimental arm.

Drug: F-02-2-Na Matching Placebo (200 mg)

B1-25mg-T

EXPERIMENTAL

The intervention consists of the multiple oral administrations of F-02-2-Na tablets at a dose of 25mg for 7 consecutive days.

Drug: F-02-2-Na Tablet (25mg)-Multiple dose

B1-25mg-R

PLACEBO COMPARATOR

The intervention consists of the multiple oral administrations of matching placebo (25mg). The administration conditions are the same as those for the experimental arm.

Drug: F-02-2-Na Matching Placebo (25mg) -Multiple dose

B2-50mg-T

EXPERIMENTAL

The intervention consists of the multiple oral administrations of F-02-2-Na tablets at a dose of 50mg for 7 consecutive days.

Drug: F-02-2-Na Tablet (50mg)-Multiple dose

B2-50mg-R

PLACEBO COMPARATOR

The intervention consists of the multiple oral administrations of matching placebo (50mg). The administration conditions are the same as those for the experimental arm.

Drug: F-02-2-Na Matching Placebo (50mg) -Multiple dose

B3-100mg-T

EXPERIMENTAL

The intervention consists of the multiple oral administrations of F-02-2-Na tablets at a dose of 100mg for 7 consecutive days.

Drug: F-02-2-Na Matching Placebo (100mg) -Multiple dose

B3-100mg-R

PLACEBO COMPARATOR

The intervention consists of the multiple oral administrations of matching placebo (100mg). The administration conditions are the same as those for the experimental arm.

Drug: F-02-2-Na Tablet (100mg)-Multiple dose

Interventions

F-02-2-Na Matching Placebo (5mg) DRUG

The intervention consists of the single oral administration of a matching placebo (5mg) for F-02-2-Na. Formulated as film-coated tablets (consistent with F-02-2-Na in appearance, color, and strength), the placebo contains no F-02-2-Na or other pharmacologically active ingredients and is manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). The administration conditions are identical to those of the experimental arm in this study; however, it has no therapeutic effect.

Also known as: A2-5mg-R

A2-5mg-R

F-02-2-Na Tablet (25mg) DRUG

The intervention involves the single oral administration of F-02-2-Na tablets at a dose of 25mg, given once in a fasting state (after at least 10 hours of fasting). The drug is formulated as film-coated tablets with a strength of 5mg/10mg per tablet, manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). Safety and PKPD parameters will be continuously monitored for 72 hours following administration. In SAD A3 (25 mg), collected blood, urine, and feces will be used for the mass balance study.

Also known as: A3-25mg-T

A3-25mg-T

F-02-2-Na Matching Placebo (25mg) DRUG

The intervention consists of the single oral administration of a matching placebo (25mg) for F-02-2-Na. Formulated as film-coated tablets (consistent with F-02-2-Na in appearance, color, and strength), the placebo contains no F-02-2-Na or other pharmacologically active ingredients and is manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). The administration conditions are identical to those of the experimental arm in this study; however, it has no therapeutic effect.

Also known as: A3-25mg-R

A3-25mg-R

F-02-2-Na Tablet (75mg) DRUG

The intervention involves the single oral administration of F-02-2-Na tablets at a dose of 75mg, given once in a fasting state (after at least 10 hours of fasting). The drug is formulated as film-coated tablets with a strength of 5mg/10mg/50mg per tablet, manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). Safety and PKPD parameters will be continuously monitored for 72 hours following administration.

Also known as: A4-75mg-T

A4-75mg-T

F-02-2-Na Matching Placebo (75mg) DRUG

The intervention consists of the single oral administration of a matching placebo (75mg) for F-02-2-Na. Formulated as film-coated tablets (consistent with F-02-2-Na in appearance, color, and strength), the placebo contains no F-02-2-Na or other pharmacologically active ingredients and is manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). The administration conditions are identical to those of the experimental arm in this study; however, it has no therapeutic effect.

Also known as: A4-75mg-R

A4-75mg-R

F-02-2-Na Tablet (150 mg) DRUG

The intervention involves the single oral administration of F-02-2-Na tablets at a dose of 150 mg, given once in a fasting state (after at least 10 hours of fasting). The drug is formulated as film-coated tablets with a strength of 50mg per tablet, manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). Safety and PKPD parameters will be continuously monitored for 72 hours following administration.

Also known as: A5-150mg-T

A5-150mg-T

F-02-2-Na Matching Placebo (150 mg) DRUG

The intervention consists of the single oral administration of a matching placebo (150 mg) for F-02-2-Na. Formulated as film-coated tablets (consistent with F-02-2-Na in appearance, color, and strength), the placebo contains no F-02-2-Na or other pharmacologically active ingredients and is manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). The administration conditions are identical to those of the experimental arm in this study; however, it has no therapeutic effect.

Also known as: A5-150mg-R

A5-150mg-R

F-02-2-Na Tablet (200 mg) DRUG

The intervention involves the single oral administration of F-02-2-Na tablets at a dose of 200 mg, given once in a fasting state (after at least 10 hours of fasting). The drug is formulated as film-coated tablets with a strength of 50mg per tablet, manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). Safety and PKPD parameters will be continuously monitored for 72 hours following administration.

Also known as: A6-200mg-T

A6-200mg-T

F-02-2-Na Matching Placebo (200 mg) DRUG

The intervention consists of the single oral administration of a matching placebo (200 mg) for F-02-2-Na. Formulated as film-coated tablets (consistent with F-02-2-Na in appearance, color, and strength), the placebo contains no F-02-2-Na or other pharmacologically active ingredients and is manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). The administration conditions are identical to those of the experimental arm in this study; however, it has no therapeutic effect.

Also known as: A6-200mg-R

A6-200mg-R

F-02-2-Na Tablet (25mg)-Multiple dose DRUG

The intervention involves the multiple oral administrations of F-02-2-Na tablets at a dose of 25mg, administered once daily for 7 consecutive days (a total of 7 administrations). The drug is formulated as film-coated tablets with a strength of 5mg/10mg per tablet, manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). Safety and PKPD parameters will be continuously monitored for 72 hours following administration.

Also known as: B1-25mg-T

B1-25mg-T

F-02-2-Na Matching Placebo (25mg) -Multiple dose DRUG

The intervention consists of the multiple oral administrations of a matching placebo (25mg) for F-02-2-Na. Formulated as film-coated tablets (consistent with F-02-2-Na in appearance, color, and strength), the placebo contains no F-02-2-Na or other pharmacologically active ingredients and is manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). The administration conditions are identical to those of the experimental arm in this study; however, it has no therapeutic effect.

Also known as: B1-25mg-R

B1-25mg-R

F-02-2-Na Tablet (50mg)-Multiple dose DRUG

The intervention involves the multiple oral administrations of F-02-2-Na tablets at a dose of 50mg, administered once daily for 7 consecutive days (a total of 7 administrations). The drug is formulated as film-coated tablets with a strength of 50mg per tablet, manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). Safety and PKPD parameters will be continuously monitored for 72 hours following administration.

Also known as: B2-50mg-T

B2-50mg-T

F-02-2-Na Matching Placebo (50mg) -Multiple dose DRUG

The intervention consists of the multiple oral administrations of a matching placebo (50mg) for F-02-2-Na. Formulated as film-coated tablets (consistent with F-02-2-Na in appearance, color, and strength), the placebo contains no F-02-2-Na or other pharmacologically active ingredients and is manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). The administration conditions are identical to those of the experimental arm in this study; however, it has no therapeutic effect.

Also known as: B2-50mg-R

B2-50mg-R

F-02-2-Na Tablet (100mg)-Multiple dose DRUG

The intervention involves the multiple oral administrations of F-02-2-Na tablets at a dose of 100mg, administered once daily for 7 consecutive days (a total of 7 administrations). The drug is formulated as film-coated tablets with a strength of 50mg per tablet, manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). Safety and PKPD parameters will be continuously monitored for 72 hours following administration.

Also known as: B3-100mg-T

B3-100mg-R

F-02-2-Na Matching Placebo (100mg) -Multiple dose DRUG

The intervention consists of the multiple oral administrations of a matching placebo (100mg) for F-02-2-Na. Formulated as film-coated tablets (consistent with F-02-2-Na in appearance, color, and strength), the placebo contains no F-02-2-Na or other pharmacologically active ingredients and is manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). The administration conditions are identical to those of the experimental arm in this study; however, it has no therapeutic effect.

Also known as: B3-100mg-R

B3-100mg-T

F-02-2-Na Tablet (0.5 mg) DRUG

The intervention involves the single oral administration of F-02-2-Na tablets at a dose of 0.5 mg, given once in a fasting state (after at least 10 hours of fasting). The drug is formulated as film-coated tablets with a strength of 1 mg per tablet, manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250901). Safety and PKPD parameters will be continuously monitored for 72 hours following administration.

Also known as: A1-0.5mg T

A1-0.5mg T

F-02-2-Na Matching Placebo (0.5mg) DRUG

The intervention consists of the single oral administration of a matching placebo (0.5mg) for F-02-2-Na. Formulated as film-coated tablets (consistent with F-02-2-Na in appearance, color, and strength), the placebo contains no F-02-2-Na or other pharmacologically active ingredients and is manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). The administration conditions are identical to those of the experimental arm in this study; however, it has no therapeutic effect.

Also known as: A1-0.5mg R

A1-0.5mg R

F-02-2-Na Tablet (5mg) DRUG

The intervention involves the single oral administration of F-02-2-Na tablets at a dose of 5mg, given once in a fasting state (after at least 10 hours of fasting). The drug is formulated as film-coated tablets with a strength of 5mg per tablet, manufactured by Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd. (batch number: 250101). Safety and PKPD parameters will be continuously monitored for 72 hours following administration.

Also known as: A2-5mg-T

A2-5mg-T

Eligibility Criteria

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

You may qualify if:

• For Healthy Adult Subjects
• 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.
• For Adult Subjects with Hyperuricemia
• \. 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.
• \. Male or female subjects aged 18 to 45 years (inclusive).
• \. Body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females; Body Mass Index (BMI) between 18 kg/m² and 28 kg/m² (inclusive).
• \. Subjects with results from vital signs check, physical examination, clinical laboratory tests (except for serum uric acid), chest X-ray, liver ultrasonography, renal ultrasonography, and 12-lead electrocardiogram that show no abnormalities or only abnormalities of no clinical significance.
• \. Estimated Glomerular Filtration Rate (eGFR) \> 90 mL/min/1.73m² (calculated using the CKD-EPI Creatinine Equation).
• \. 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 ova donation.

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)

• 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

• 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

• 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

• 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

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: January 7, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)