万邦德石杉碱甲口服溶液启动Ⅰ期临床 适应症为重症肌无力

Group 1 - The core focus of the news is the initiation of a Phase I clinical trial for Wanbangde Pharmaceutical Group's oral solution and injection of Huperzine A, aimed at comparing their pharmacokinetic characteristics in healthy Chinese subjects [1] - The clinical trial is designed as a single-center, randomized, open-label, single-dose, two-period, two-sequence, crossover study, with a registration number of CTR20255231 and the first public information date set for December 30, 2025 [1] - The primary objective of the trial is to compare the pharmacokinetic profiles of the oral solution and injection of Huperzine A under fasting conditions, while secondary objectives include assessing the relative bioavailability of the oral solution and the safety of both formulations [1] Group 2 - The main endpoints of the trial include pharmacokinetic parameters such as Cmax, AUC0-t, and AUC0-∞, while secondary endpoints include Tmax, λz, t1/2, AUC_%Extrap, CL/F, Vz/F, relative bioavailability F, physical examinations, vital signs, 12-lead ECG, laboratory tests, and adverse events [2] - The current status of the trial is ongoing, with a target enrollment of 20 participants, although recruitment has not yet started [2]