Sonnet Bio Reveals Pharmacokinetic, Pharmacodynamic Data In Early-Stage SON-1010 Trial
Sonnet Bio Reveals Pharmacokinetic, Pharmacodynamic Data In Early-Stage SON-1010 Trial
Sonnet Bio 在早期的 SON-1010 试验中公布了药代动力学、药效学数据
- 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.
- 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.
- Sonnet Biotherautics 纳斯达克股票代码：SONN）宣布，其针对健康志愿者的1期试验已经完成了 SON-1010 剂量的药代动力学（PK）谱模拟。
- 该公司表示，安全审查委员会迄今尚未发现任何重大的安全问题，并已批准提高到更高的剂量水平。
- 皮下给药后，SON-1010 出现典型的剂量相关增加。药物水平在大约11小时达到峰值，50、100和150 ng/kg剂量组的几何平均最大浓度（Cmax）分别为29、68和125 pg/mL。
- 相关： Sonnet BioTherapeutics 重点介绍了主要癌症候选人的安全。
- 服用 150 ng/kg 剂量 SON-1010 后的平均消除半衰期 (T1⁄2) 为 112 小时，而 rHIL-12 的平均消除半衰期 (T1⁄2) 为 12 小时。
- 观察到的IfNG增多最为明显，与剂量相关、控制和延长。SON-1010 在所有活性药物受试者中诱导 IfNG，在 24 至 48 小时达到峰值，然后在两周后恢复到基线。
- 低量的 IL-10 是以剂量依赖性方式诱导的，这也可能是由于干扰素含量增加所致。给药后，IL-6、IL-8和TNFα出现了小幅的短暂增加，但没有看到一致的模式。没有细胞因子释放综合征的证据。
- 价格走势： 在周四的最后一张支票中，SONN股价下跌8.80％，至1.1491美元。
译文内容由第三方软件翻译。
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