Canadian biopharma company Algernon Pharmaceuticals Inc. (OTCQB:AGNPF)'s subsidiary Algernon NeuroScience (AGN Neuro) completed dosing the second cohort of its Phase 1 study on the company's proprietary IV formulation of DMT, AP-188. It is now moving forward with the final cohort at an escalated dose after no safety or tolerability issues were found.
The trial, conducted at the Centre for Human Drug Research (CHDR) in the Netherlands, aims to identify the safety, tolerability and pharmacokinetics of the hallucinogenic tryptamine drug administered as an IV bolus followed by a prolonged infusion of 6 hours.
After establishing the correct dose and optimum exposure period in the first part of the study, the second part will include dosing subjects for six hours with repeated dosing over a two-week period.
See also: MDMA Transdermal Patch Moves Toward First-In-Human Trials: Latest Development Update
Phase 2 study design is also underway. Led by Algernon's stroke and traumatic brain injury (TBI) experts, the next-stage trial would assess DMT therapy's effects on patients with serious brain injuries.
Algernon has filed patents for novel salt forms of DMT (pamoate and nicotinate) as well as claims on formulation, dosage and usage methods for ischemic stroke and the combination therapy of DMT and stroke rehabilitation, including Constraint Induced Movement Therapy.
The company is supplying Yale University with its psychedelic compound for an investigator-initiated clinical trial assessing multiple IV doses of DMT for the treatment of depression.
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加拿大生物制药公司Algernon PharmPharmticals Inc.(OTCQB:AGNPF)的子公司Algernon Neuro(AGN Neuro)完成了对该公司专有的DMT IV配方AP-188进行的第一阶段研究的第二组剂量。在没有发现安全性或耐受性问题后,该公司现在正在以更高的剂量进行最后一组试验。
这项试验在荷兰的人类药物研究中心(CHDR)进行,旨在确定致幻色胺药物的安全性、耐受性和药代动力学,以静脉推注的形式给药,然后长时间输注6小时。
在第一部分确定了正确的剂量和最佳暴露时间后,第二部分将包括在两周内重复给药,给受试者服用六个小时的剂量。
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第二阶段的研究设计也在进行中。由Algernon的中风和创伤性脑损伤(TBI)专家领导的下一阶段试验将评估DMT疗法对严重脑损伤患者的效果。
Algernon已经为新型盐形式的DMT(帕莫酸盐和尼古丁)申请了专利,并申请了治疗缺血性中风的配方、剂量和使用方法的权利要求,以及DMT和中风康复的组合疗法,包括强制性诱导运动疗法。
该公司正在为耶鲁大学提供迷幻化合物,用于一项由研究人员发起的临床试验,评估多次静脉剂量的DMT治疗抑郁症。
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