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舒泰神:取得STSA-1301皮下注射液用于治疗原发性免疫性血小板减少症的Ia期临床研究总结报告

Staidson: Summary report of the phase Ia clinical study of STSA-1301 subcutaneous injection for the treatment of primary immune thrombocytopenia.

Breakings ·  Aug 8 16:37

Staidson announced that the summary report of Phase I clinical study of STSA-1301 subcutaneous injection for the treatment of primary immune thrombocytopenia was obtained. The results showed that the safety and tolerability of STSA-1301 subcutaneous injection in healthy subjects after a single dose were good, exhibiting non-linear pharmacokinetic characteristics. It can dose-dependently reduce the serum total IgG level, with the maximum decrease occurring between 5-14 days after administration. There was some immunogenicity in the high-dose group but there were no observed effects on PK, PD, and safety. No effects were observed on IgA, IgM, IgD, IgE, and cytokines.

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