Back
For best output, select "Paper Size" as "A4" and "Margin" as "0" or "None".
To save or print to PDF, please select Print Destination > Save as PDF, enable Background Graphics under "More Settings", then click "Save".
During the congress, E-Posters will be accessible to all participants on the congress website 24/7, as well as in the E-poster stations in the congress center.
Preparing your E-Poster
Please review the E-Poster format requirements carefully when preparing your E-Poster. Should your E-Poster not meet the mentioned requirements, it may not be displayed as described above.
E-Poster Submission Deadline
Please prepare and upload your E-Poster no later than March 14, 2026 11.59PM CET. After this date, you will no longer be able to prepare and upload your E-poster and it will not be displayed and accessible on the congress website.
Please follow the instructions below to input your abstract title.
Abstract titles should be brief and reflect the content of the abstract.
An over-active alternative complement pathway has been implicated in the pathophysiology of multiple diseases, including paroxysmal nocturnal hemoglobinuria and IgA nephropathy. HS-10542 is a once-daily oral selective small-molecule inhibitor of complement factor B, a key component of the alternative pathway. This first-in-human study assessed the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-10542 in healthy Chinese participants.
This was a randomized, placebo-controlled, double-blind, single-center phase 1 study (NCT07040046) consisting of single-ascending-dose (SAD) and multiple-ascending-dose (MAD) parts. This study included 32 participants in the SAD part (from 100 mg to 800 mg) and 37 participants in MAD part (from 100 mg QD to 400 mg QD for 10 days).
Safety and tolerability were assessed by adverse events (AEs) and changes in laboratory parameters. Blood samples were collected to measure plasma concentrations of HS-10542 at predefined time points, and PD analysis was conducted by measuring complement alternative pathway (AP) activity with WIESLAB assay.
A total of 69 participants were enrolled, 32 in SAD and 35 in MAD receiving either HS-10542 or placebo. HS-10542 was well tolerated.
Safety Assessment: No deaths, serious adverse events (SAEs) or severe adverse events (AEs) were reported. All treatment-emergent adverse events (TEAEs) were mild. TEAEs were comparable between the HS-10542 groups and placebo groups in SAD (62.5% vs. 62.5%) and in MAD (76.9% vs. 88.9%) parts. No significantly increasing trend in the incidence of TEAEs was observed in MAD part.
PK: HS-10542 was rapidly absorbed, with a median Tmax of 1~2 hours. The terminal half-life was moderately long at 26 to 33 hours following single doses. Systemic exposure increase was less than dose proportional following both single and multiple doses. There was a low accumulation ratio of 1.2 to 1.3-fold following multiple doses.
PD: Robust AP inhibition (87.5-100%) was achieved by HS-10542 across doses of SAD within 24 hours. Throughout all time points up to 24 hours after last dosing of MAD, mean inhibition of AP exceeded 90% (92-100%) across doses, with >95% inhibition at 24 hours after last dosing of MAD across doses.
Conclusions: HS-10542 demonstrated favorable tolerability, safety, PK and robust inhibition of AP activity, supporting once daily dosing in clinical trials of complement-mediated diseases.
