{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["18(3)"],"submitter":["Liu Y"],"pubmed_abstract":["SC1011 (sufenidone) is a novel pyridone derivative with therapeutic potential for idiopathic pulmonary fibrosis (IPF). Two Phase 1 studies evaluated the safety and pharmacokinetics of single (SAD) and multiple ascending doses (MAD) of SC1011 immediate-release (IR) and modified-release (MR) oral formulations in healthy adult subjects. In Phase 1a, subjects were randomized to receive oral SC1011 IR or placebo in SAD (50 mg-300 mg) or MAD (100 mg and 200 mg) twice daily for 7 days. The Phase 1b study consisted of three treatment groups that received 100, 150, or 200 mg SC1011 MR twice daily for 7 days. SC1011 IR was absorbed rapidly (mean time to maximum concentration, T<sub>max</sub> ≤ 1 h) and eliminated rapidly (mean terminal half-life, t<sub>1/2</sub>: 1.23-2.64 h) following 50-300 mg sin"],"journal":["Clinical and translational science"],"pagination":["e70179"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11893723"],"repository":["biostudies-literature"],"pubmed_title":["Safety, Tolerability, and Pharmacokinetics of SC1011 (Sufenidone), a Novel Antifibrotic Small Molecule, in Phase 1 Studies in Healthy Subjects."],"pmcid":["PMC11893723"],"pubmed_authors":["Qian H","Jiang F","Zan B","Zhu H","Du Y","Liu S","Zeng Y","Sun X","Tang H","Liu Y","Li Y","Yang Z","Ge Z","Chen X","Tang Y"],"additional_accession":[]},"is_claimable":false,"name":"Safety, Tolerability, and Pharmacokinetics of SC1011 (Sufenidone), a Novel Antifibrotic Small Molecule, in Phase 1 Studies in Healthy Subjects.","description":"SC1011 (sufenidone) is a novel pyridone derivative with therapeutic potential for idiopathic pulmonary fibrosis (IPF). Two Phase 1 studies evaluated the safety and pharmacokinetics of single (SAD) and multiple ascending doses (MAD) of SC1011 immediate-release (IR) and modified-release (MR) oral formulations in healthy adult subjects. In Phase 1a, subjects were randomized to receive oral SC1011 IR or placebo in SAD (50 mg-300 mg) or MAD (100 mg and 200 mg) twice daily for 7 days. The Phase 1b study consisted of three treatment groups that received 100, 150, or 200 mg SC1011 MR twice daily for 7 days. SC1011 IR was absorbed rapidly (mean time to maximum concentration, T<sub>max</sub> ≤ 1 h) and eliminated rapidly (mean terminal half-life, t<sub>1/2</sub>: 1.23-2.64 h) following 50-300 mg sin","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Mar","modification":"2025-04-26T02:41:01.958Z","creation":"2025-04-06T10:36:33.504Z"},"accession":"S-EPMC11893723","cross_references":{"pubmed":["40065557"],"doi":["10.1111/cts.70179"]}}