我武生物取得烟曲霉点刺液I期临床试验总结报告

Group 1 - The company, Iwubio (300357.SZ), has completed a Phase I clinical study on its developed product "Fumigatus Puncture Solution" to explore its safety and efficacy in Chinese volunteers [1] - The study reported good safety within the set dosage range (55DU/mL-495000DU/mL), with adverse events being classified as Grade 1 or 2, and no serious adverse reactions or events leading to withdrawal [1] - A certain proportion of delayed reactions were observed among subjects, potentially related to the fungal nature of Fumigatus [1] Group 2 - The specificity of the product at all dosages was above 95%, with no dose-related effects observed; however, sensitivity showed an increasing trend with higher dosages, reaching 95% at a dosage of 55000DU/mL [1] - Researchers recommend advancing the product into further clinical studies using dosages of 55000DU/mL and above, while also suggesting exploration of better strategies to reduce delayed reactions from a pharmaceutical perspective before subsequent clinical trials [1]