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 range

18 Years – 45 Years

Sex

ALL

See this in plain English?

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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.

Trial details

NCT IDNCT07324434

SponsorGuangdong Hengqin Novagains Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-01

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