Trial reportFrontiers in pharmacology2026
Pharmacokinetics and safety of SHR0302, a selective JAK1 inhibitor, in Chinese patients with hepatic impairment.
Trial report in Frontiers in pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04293029 (Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study), which is not on this map. Not yet cited in PubMed.
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Pharmacokinetics and Safety of SHR0302 in Patients With Mild, Moderate Hepatic Impairment and Normal Liver Function in Phase I Clinical Study
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Authors and funding
7 authors.
Funding
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Abstract
Objective: To evaluate the effects of mild and moderate hepatic impairment on the pharmacokinetics and safety of SHR0302. Methods: This open-label, parallel-group study enrolled 24 Chinese subjects, including subjects with normal hepatic function and those with mild or moderate hepatic impairment (8 per group). All subjects received a single oral dose of SHR0302 (8 mg). Plasma PK parameters of SHR0302 and its metabolite, SHR161279, were assessed and compared across groups. Safety was evaluated throughout the study. Results: Mild hepatic impairment had minimal effect on the exposure of SHR0302. In subjects with moderate hepatic impairment, the C Conclusion: Mild and moderate hepatic impairment had minimal effect on SHR0302 exposure. Based on the single-dose pharmacokinetic and safety data, dose adjustment of SHR0302 may not be necessary in patients with mild or moderate hepatic impairment. Clinical Trial Registration: https://clinicaltrials.gov/, identifier NCT04293029.
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