本试验旨在评价中国成年男性健康受试者单剂量口服[14C] WXFL10203614的吸收、代谢和排泄，揭示受试物在人体内的药代动力学整体特征，为药物的临床合理使用提供参考。主要目的 1.定量分析受试者单次口服[14C]WXFL10203614后排泄物中的总放射性，获得人体放射性排泄率数据和主要排泄途径； 2.获得受试者口服[14C]WXFL10203614后人血浆、尿液和粪便的放射性代谢物谱，鉴定主要代谢产物，确定代谢途径及消除途径。 3.定量分析受试者单次口服[14C]WXFL10203614后全血和血浆中的总放射性，并考察全血和血浆中总放射性的分配情况。次要目的 1.采用已验证的液相色谱串联质谱联用法（LC-MS/MS）定量分析血浆中WXFL10203614及其代谢产物（如适用）的浓度，获得血浆中WXFL10203614及其代谢产物（如适用）的药动学参数。观察[14C]WXFL10203614单次给药后受试者的安全性。

[Translation]

This study aims to evaluate the absorption, metabolism and excretion of [14C] WXFL10203614 after a single oral dose in healthy adult male subjects in China, reveal the overall pharmacokinetic characteristics of the test substance in the human body, and provide a reference for the rational clinical use of the drug. Main objectives 1. Quantitatively analyze the total radioactivity in the excreta of subjects after a single oral dose of [14C] WXFL10203614, and obtain the data on the excretion rate of human radioactivity and the main excretion pathway; 2. Obtain the radioactive metabolite spectrum of human plasma, urine and feces after oral administration of [14C] WXFL10203614, identify the main metabolites, and determine the metabolic pathways and elimination pathways. 3. Quantitatively analyze the total radioactivity in whole blood and plasma of subjects after a single oral dose of [14C] WXFL10203614, and investigate the distribution of total radioactivity in whole blood and plasma. Secondary objectives 1. To quantitatively analyze the concentration of WXFL10203614 and its metabolites (if applicable) in plasma using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method, and obtain the pharmacokinetic parameters of WXFL10203614 and its metabolites (if applicable) in plasma. To observe the safety of subjects after a single dose of [14C]WXFL10203614.

Start Date19 Sep 2024

Sponsor / Collaborator

Wuxi Fuxin Pharmaceutical Research and Development Co., Ltd.

CTR20242349 / RecruitingPhase 1

评价WXFL10203614片在轻度、中度肝功能损害和肝功能正常受试者中的药代动力学和安全性的I期临床研究

[Translation] A Phase I clinical study to evaluate the pharmacokinetics and safety of WXFL10203614 tablets in subjects with mild, moderate hepatic impairment and normal hepatic function

主要目的评价 WXFL10203614片在轻度肝功能损害（Child-Pugh A）、中度肝功能损害（Child-Pugh B）和肝功能正常受试者中的药代动力学，为 WXFL10203614片的临床应用提供依据。次要目的评价 WXFL10203614片在轻度肝功能损害（Child-Pugh A）、中度肝功能损害（Child-Pugh B）和肝功能正常受试者中的安全性。

[Translation]

Primary objective To evaluate the pharmacokinetics of WXFL10203614 tablets in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B) and normal hepatic function, and to provide a basis for the clinical application of WXFL10203614 tablets. Secondary objective To evaluate the safety of WXFL10203614 tablets in subjects with mild hepatic impairment (Child-Pugh A), moderate hepatic impairment (Child-Pugh B) and normal hepatic function.

Start Date17 Jul 2024

Sponsor / Collaborator

Wuxi Fuxin Pharmaceutical Research and Development Co., Ltd.

CTR20231989 / RecruitingPhase 3

评价WXFL10203614片治疗中重度活动性类风湿关节炎(RA)有效性和安全性的随机、双盲双模拟、多中心、阳性药及安慰剂对照的III期临床研究

[Translation] A randomized, double-blind, double-dummy, multicenter, active drug and placebo-controlled Phase III clinical study to evaluate the efficacy and safety of WXFL10203614 tablets in the treatment of moderately to severely active rheumatoid arthritis (RA)

主要目的：评价WXFL10203614片治疗中重度活动性类风湿关节炎(RA)的有效性；次要目的：评价WXFL10203614片治疗中重度活动性类风湿关节炎(RA)的安全性和群体药代动力学特征。

[Translation]

Primary purpose: To evaluate the effectiveness of WXFL10203614 tablets in the treatment of moderately to severely active rheumatoid arthritis (RA); Secondary purpose: To evaluate the safety and population pharmacokinetic characteristics of WXFL10203614 tablets in the treatment of moderately to severely active rheumatoid arthritis (RA).

Start Date28 Sep 2023

Sponsor / Collaborator

Wuxi Fuxin Pharmaceutical Research and Development Co., Ltd.

100 Clinical Results associated with Wuxi Fuxin Pharmaceutical Research and Development Co., Ltd.

0 Patents (Medical) associated with Wuxi Fuxin Pharmaceutical Research and Development Co., Ltd.

Literatures (Medical) associated with Wuxi Fuxin Pharmaceutical Research and Development Co., Ltd.

Frontiers in Pharmacology

The effect of food on the pharmacokinetics of WXFL10203614, a potential selective JAK1 inhibitor, in healthy Chinese subjects

Article

Author: Gu, Xianghong ; Shi, Yunfei ; Huang, Kai ; Qin, Wei ; Que, Linling ; Xu, Jianguo ; Chu, Nannan ; Wang, Jiakun ; Qian, Zhenzhong ; Ding, Ying ; Zhang, Zhiwei ; He, Qing

Objective: This study was performed to investigate the effect of food on the pharmacokinetics (PK) of WXFL10203614 in healthy Chinese subjects.Methods: This was a randomized, open-label, single-dose, two-treatment (fed vs fasted), two-period, two-sequence, crossover study. 14 eligible subjects were averagely randomized into 2 sequences and then received 10 mg WXFL10203614 under fasted or fed condition. In each period, the blood samples were collected from 0 h (pre-dose) and serially up to 72 h post-dose, and plasma concentrations were detected using the high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. The effect of food on the PK profile and safety of WXFL10203614 were assessed.Results: 70 subjects were screened, and 14 subjects (10 male and 4 female) were enrolled and completed the study. Under the fasted condition, WXFL10203614 was absorbed rapidly with a Tmax of 0.98 h. The absorption rate was slower, Tmax delayed by 2.98 h, and the Cmax decreased by 16.3% when WXFL10203614 administered after the high-fat and high-calorie diet, other PK parameters were not affected. The 90% confidence intervals (CIs) for the ratio (fed/fasted) of geometric means of the Cmax, AUC0-t and AUC0-∞ were 0.73–1.01, 0.90–1.03 and 0.90–1.03, indicating that the high-fat and high-calorie diet might impact the absorption process of WXFL10203614. Although the Cmax was slightly decreased, there was no significant difference in the Cmax under fasted and fed conditions. Thus, it was not considered clinically significant owing to the small magnitude of changes in Cmax. All Treatment-emergent adverse events (TEAEs) were mild and resolved spontaneously without treatment.Conclusion: Food had no clinically relevant effects on drug system exposure of WXFL10203614. It was well tolerated under fasted and fed conditions in healthy Chinese subjects, so WXFL10203614 could be administered orally with or without food.Clinical Trial Registration: http://www.chinadrugtrials.org.cn/index.html, identifier CTR20191636.

Frontiers in Pharmacology

Safety, tolerability and pharmacokinetics of WXFL10203614 in healthy Chinese subjects: A randomized, double-blind, placebo-controlled phase Ⅰ study

Article

Author: Xu, Jianguo ; Chu, Nannan ; Chen, Yuanxin ; Huang, Kai ; Qin, Wei ; Gu, Xianghong ; Zhang, Zhiwei ; Ding, Ying ; Shi, Yunfei ; Que, Linling ; He, Qing ; Qian, Zhenzhong ; Wang, Jiakun

Objective: This study was conducted to investigate the safety, tolerability and pharmacokinetics (PK) of WXFL10203614 after single and multiple oral doses in healthy Chinese subjects.Methods: A single-center, randomized, double-blind, placebo-controlled phase Ⅰ study was performed on healthy Chinese subjects. In the single-dose study, Subjects were randomized into 7 dose levels of WXFL10203614 (1 mg group, n = 2; 2, 5, 10, 17, 25 and 33 mg groups with placebo, 8 subjects per group, 2 of them given placebo). In the multiple-dose study, subjects received 5 or 10 mg WXFL10203614 once daily (QD), 5 mg twice daily (BID) or placebo for 7 consecutive days. Safety, tolerability and PK of WXFL10203614 were all assessed.Results: A total of 592 subjects were screened, 50 subjects were enrolled in the single-dose study and 30 in the multiple-dose study. All adverse events (AEs) were mild or moderate and resolved spontaneously. No Serious Adverse Events (SAEs) or deaths were reported during the study. WXFL10203614 was absorbed rapidly after dosing with Tmax of 0.48–0.98 h, Cmax, AUC0-t and AUC0-∞ were all increased in a dose-related manner over the range of 1–33 mg. Renal excretion was the major route of elimination of WXFL10203614. Steady-state PK parameters (Cmax,ss, AUC0-t,ss and AUC0-∞,ss) were elevated after once-daily administration of 5–10 mg WXFL10203614 and non- and weak drug accumulations were observed, whereas moderate drug accumulation occurred in the 5 mg BID group.Conclusion: WXFL10203614 exhibited good safety, tolerability and favorable PK profiles in healthy Chinese subjects, supporting further clinical development in patients with rheumatoid arthritis.Clinical Trials Registration Number:http://www.chinadrugtrials.org.cn/index.html, #CTR20190069 and CTR20200143.

100 Deals associated with Wuxi Fuxin Pharmaceutical Research and Development Co., Ltd.

100 Translational Medicine associated with Wuxi Fuxin Pharmaceutical Research and Development Co., Ltd.

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Drug(Targets)	Indications	Global Highest Phase

WXFL10203614 ( JAK1 )	Rheumatoid Arthritis More	Phase 3

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