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MIRA Pharmaceuticals | 8-K: Current report

MIRA Pharmaceuticals | 8-K: Current report

MIRA Pharmaceuticals | 8-K:重大事件
美股SEC公告 ·  2024/12/10 13:49

牛牛AI助理已提取核心訊息

MIRA Pharmaceuticals has successfully completed its Good Laboratory Practice (GLP) preclinical safety program for Ketamir-2, a novel oral ketamine analog, with no adverse findings reported. The comprehensive safety evaluation included cardiovascular tests in dogs, CNS and respiratory assessments in rats, and a 14-day toxicology study, all showing positive results with no significant adverse effects at therapeutic doses.The company plans to submit its Investigational New Drug (IND) application by the end of 2024, followed by the initiation of Phase I clinical trials in Q1 2025. The upcoming trials will focus on safety, tolerability, pharmacokinetics, and pharmacodynamics, with specific attention to pain evaluation metrics for treating neuropathic pain and psychosis. Early data from these trials is expected by Q2 2025.
MIRA Pharmaceuticals has successfully completed its Good Laboratory Practice (GLP) preclinical safety program for Ketamir-2, a novel oral ketamine analog, with no adverse findings reported. The comprehensive safety evaluation included cardiovascular tests in dogs, CNS and respiratory assessments in rats, and a 14-day toxicology study, all showing positive results with no significant adverse effects at therapeutic doses.The company plans to submit its Investigational New Drug (IND) application by the end of 2024, followed by the initiation of Phase I clinical trials in Q1 2025. The upcoming trials will focus on safety, tolerability, pharmacokinetics, and pharmacodynamics, with specific attention to pain evaluation metrics for treating neuropathic pain and psychosis. Early data from these trials is expected by Q2 2025.
MIRA製藥公司已成功完成其良好實驗室規範(GLP)臨牀前安全程序,針對Ketamir-2這一新型口服氟氮平類似物,未報告不良發現。全面的安全評估包括對狗的心血管測試、對大鼠的中樞神經系統和呼吸評估,以及爲期14天的毒理學研究,所有結果均顯示在治療劑量下沒有顯著的不良影響。該公司計劃於2024年底提交其新的臨牀試驗申請(IND),並於2025年第一季度啓動I期臨牀試驗。即將進行的試驗將重點關注安全性、耐受性、藥代動力學和藥效學,特別關注用於治療神經性疼痛和精神病的疼痛評估指標。預計這些試驗的早期數據將在2025年第二季度公佈。
MIRA製藥公司已成功完成其良好實驗室規範(GLP)臨牀前安全程序,針對Ketamir-2這一新型口服氟氮平類似物,未報告不良發現。全面的安全評估包括對狗的心血管測試、對大鼠的中樞神經系統和呼吸評估,以及爲期14天的毒理學研究,所有結果均顯示在治療劑量下沒有顯著的不良影響。該公司計劃於2024年底提交其新的臨牀試驗申請(IND),並於2025年第一季度啓動I期臨牀試驗。即將進行的試驗將重點關注安全性、耐受性、藥代動力學和藥效學,特別關注用於治療神經性疼痛和精神病的疼痛評估指標。預計這些試驗的早期數據將在2025年第二季度公佈。

譯文內容由第三人軟體翻譯。


牛牛AI助手部分由第三方人工智慧模型基於資訊內容自動產生。


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