By InvitationPhase 1

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

China69 participantsStarted 2025-12-15

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * For Healthy Adult Subjects * 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. * For Adult Subjects with Hyperuricemia * 1\. The subjects should fully understand the pur…

What they're measuring

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

Timeframe: 0-72 hours post dose

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

Timeframe: 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

Timeframe: 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.

Timeframe: 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.

Timeframe: 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.

Timeframe: 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

Trial details

NCT IDNCT07324434

SponsorGuangdong Hengqin Novagains Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07-01

View on ClinicalTrials.gov More Hyperuricemia With or Without Gout trials