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

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

Interventions

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

DRUG

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

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.

Sponsors & Collaborators

• Xiangbei Welman Pharmaceutical Co., Ltd

  collaborator INDUSTRY

• Guangzhou Xin-Chuangyi Biopharmaceutical Co., Ltd.

  collaborator UNKNOWN

• Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Junyan Wu, MS · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

• Donghui Zheng, MM · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-12-15

Primary Completion

2026-07-01

Completion

2026-09-01

FDA Drug

Yes

Countries

• China

Study Locations