drugset / Trial / NCT07324434
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects
Phase 1
Enrolling by invitation
69 enrolled
Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Guangzhou Xin-Chuangyi Biopharmaceutical Co., Ltd. · collabXiangbei Welman Pharmaceutical Co., Ltd · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-12-15
- Primary completion
- 2026-10-01
- Completion
- 2026-12-01
Publications
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | F-02-2-Na | Unknown | 0.5 mg | Oral |
| Subject | F-02-2-Na | Unknown | 5 mg | Oral |
| Subject | F-02-2-Na | Unknown | 10 mg | Oral |
| Subject | F-02-2-Na | Unknown | 20 mg | Oral |
| Subject | F-02-2-Na | Unknown | 25 mg | Oral |
| Subject | F-02-2-Na | Unknown | 40 mg | Oral |
| Subject | F-02-2-Na | Unknown | 50 mg | Oral |
| Subject | F-02-2-Na | Unknown | 60 mg | Oral |
| Subject | F-02-2-Na | Unknown | 100 mg | Oral |
Indications
No indication recorded.