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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 ·  11/19 15:12

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MIRA Pharmaceuticals has chosen The Centre for Human Drug Research (CHDR) in Leiden, Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. The trial will utilize CHDR's proprietary PainCart® technology, enabling early efficacy assessment in healthy subjects during Phase I, a unique capability at this stage.Recruitment for the trial is scheduled to begin in Q1 2025, with initial safety and efficacy results from the Phase I study expected in H2 2025. The Phase IIa study, focusing on diabetic neuropathy patients, is planned to start in Q4 2025, with initial human efficacy results anticipated in H1 2026.The selection of CHDR was primarily driven by its PainCart® technology, which allows MIRA to gain valuable insights into Ketamir-2's potential for pain management earlier in the clinical process, along with safety and pharmacokinetic information. Psychoactivity assessments will be conducted separately as part of an independent evaluation.
MIRA Pharmaceuticals has chosen The Centre for Human Drug Research (CHDR) in Leiden, Netherlands, as the site for its Phase I/IIa clinical trial of Ketamir-2, a novel oral ketamine analog. The trial will utilize CHDR's proprietary PainCart® technology, enabling early efficacy assessment in healthy subjects during Phase I, a unique capability at this stage.Recruitment for the trial is scheduled to begin in Q1 2025, with initial safety and efficacy results from the Phase I study expected in H2 2025. The Phase IIa study, focusing on diabetic neuropathy patients, is planned to start in Q4 2025, with initial human efficacy results anticipated in H1 2026.The selection of CHDR was primarily driven by its PainCart® technology, which allows MIRA to gain valuable insights into Ketamir-2's potential for pain management earlier in the clinical process, along with safety and pharmacokinetic information. Psychoactivity assessments will be conducted separately as part of an independent evaluation.
MIRA Pharmaceuticals 选择荷兰莱顿的中心人类药物研究 (CHDR) 作为其 Ketamir-2 临床试验 I/IIa 阶段的地点,该药物是一种新型口服氯胺酮类药物。该试验将利用 CHDR 的专有 PainCart® 科技,使得在 I 期阶段可以在健康受试者中进行早期疗效评估,这是这一阶段的独特能力。试验招募预计于 2025 年第一季度开始,I 期研究的初步安全性和疗效结果预计将在 2025 年下半年公布。 IIa 阶段研究将重点关注糖尿病神经病变患者,计划在 2025 年第四季度开始,初步人类疗效结果预计在 2026 年上半年公布。选择 CHDR 主要是因为其 PainCart® 技术,这使得 MIRA 能够在临床过程中更早地获得有关 Ketamir-2 在疼痛管理方面潜力的有价值见解,以及安全性和药代动力学信息。心理活性评估将作为独立评估的一部分另行进行。
MIRA Pharmaceuticals 选择荷兰莱顿的中心人类药物研究 (CHDR) 作为其 Ketamir-2 临床试验 I/IIa 阶段的地点,该药物是一种新型口服氯胺酮类药物。该试验将利用 CHDR 的专有 PainCart® 科技,使得在 I 期阶段可以在健康受试者中进行早期疗效评估,这是这一阶段的独特能力。试验招募预计于 2025 年第一季度开始,I 期研究的初步安全性和疗效结果预计将在 2025 年下半年公布。 IIa 阶段研究将重点关注糖尿病神经病变患者,计划在 2025 年第四季度开始,初步人类疗效结果预计在 2026 年上半年公布。选择 CHDR 主要是因为其 PainCart® 技术,这使得 MIRA 能够在临床过程中更早地获得有关 Ketamir-2 在疼痛管理方面潜力的有价值见解,以及安全性和药代动力学信息。心理活性评估将作为独立评估的一部分另行进行。
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