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Sonnet Bio Reveals Pharmacokinetic, Pharmacodynamic Data In Early-Stage SON-1010 Trial

Sonnet Bio Reveals Pharmacokinetic, Pharmacodynamic Data In Early-Stage SON-1010 Trial

十四行詩生物在早期 SON-1010 試驗中揭示藥代動力學,藥效學數據
Benzinga Real-time News ·  2023/01/20 00:31
  • Sonnet BioTherapeutics Holdings Inc (NASDAQ:SONN) announced that pharmacokinetic (PK) profile simulation of SON-1010 dosing had been completed in its Phase 1 trial in healthy volunteers.
  • The Safety Review Committee has found no significant safety concerns to date and has approved advancing to each higher dose level, the company said.
  • Typical dose-related increases were seen with SON-1010 after subcutaneous administration. Drug levels peaked at about 11 hours with a geometric mean maximum concentration (Cmax) of 29, 68, and 125 pg/mL for the 50, 100, and 150 ng/kg dose groups, respectively.
  • Related: Sonnet BioTherapeutics Highlights Safety Profile For Lead Cancer Candidate.
  • The mean elimination half-life (T1⁄2) after a 150 ng/kg dose of SON-1010 was 112 hours, compared to 12 hours for rhIL-12.
  • Observed increases in IFNg were most pronounced and were dose-related, controlled, and prolonged. SON-1010 induced IFNg in all active-drug subjects, which peaked at 24 to 48 hours and then returned to baseline after two weeks.
  • Low amounts of IL-10 were induced in a dose-dependent manner, which could also be due to the increase in IFNg. After dosing, there were small transient increases in IL-6, IL‐8, and TNFα, but no consistent pattern was seen. There was no evidence of cytokine release syndrome.
  • Price Action: SONN shares are down 8.80% at $1.1491 on the last check Thursday.
  • 十四行詩生物治療控股有限公司 (NASDAQ: SONN) 宣布,SON-1010 給藥的藥代動力學 (PK) 輪廓模擬已在健康志願者的第一階段試驗中完成。
  • 該公司表示,安全審查委員會迄今為止沒有發現任何重大安全問題,並已批准推進到每個較高劑量水平。
  • 皮下給藥後,SON-1010 可以看到典型的劑量相關的增加。藥物水平達到高峰約 11 與幾何平均最大濃度小時 (C 最大) 的 29, 68, 和 125 微克/毫升為50, 100, 和 150 毫微克/公斤劑量組, 分別.
  • 相關: 十四行詩生物治療學強調鉛癌候選人的安全性概況
  • 平均消除半衰期 (1 ⁄2) 後 150 毫微克/公斤劑量的 SON-1010 是 112 小時, 相比 12 小時為人類 -12.
  • iFNG 中觀察到的增加最明顯,並且與劑量相關,受控和延長。SON-1010 在所有活性藥物受試者中引起 iFNG,達到高峰期達到 24 至 48 小時,然後在兩週後恢復基線。
  • 低量的 IL-10 是以劑量依賴性的方式誘導的,這也可能是由於 iFNG 的增加。在給藥後,IL-6、IL‑8 和 TNFα 有小暫態增加,但沒有看到一致的模式。沒有證據顯示細胞因子釋放綜合徵。
  • 價格行動: 上次檢查星期四,SONN 股價下跌 8.80%,為 1.1491 美元。

譯文內容由第三人軟體翻譯。


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