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Psycheceutical to Conduct the First Ever Phase I and II Clinical Trials of a Novel Ketamine Topical Cream to Treat PTSD
Psycheceutical to Conduct the First Ever Phase I and II Clinical Trials of a Novel Ketamine Topical Cream to Treat PTSD.
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[{"type":"text","content":"\n Psycheceutical ​​enters into agreement with iNGENū to conduct ​human ​clinical trials of NeuroDirect™ ketamine topical ​in AustraliaPhase I trial will study 20 people to test the safety, tolerability, and pharmacokinetics of a single dose of NeuroDirect™ ketaminePhase II trial will study 115 participants with PTSD and look at the effectiveness of NeuroDirect™ ketamine on improving their symptoms MIAMI, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Psycheceutical Bioscience, Inc. (OTCPK: BWVI) (\"Psycheceutical\" or the \"Company\"), a bioscience company dedicated to developing cutting-edge technologies for the next generation of mental health treatments, today announced it has entered into an exclusive agreement with iNGENū Pty Ltd. (\"iNGENū\"), an Australian-based Contract Research Organization (CRO), to design and conduct two clinical trials to evaluate Psycheceutical’s patented NeuroDirect™ ketamine topical delivery system. Psycheceutical​​ ​is planning to conduct the clinical trials in ​​Australia. The first in-human, Phase I clinical trial with iNGENū is studying 20 people, each dosed with a single application of NeuroDirect™ ketamine. This trial is designed to test the “Safety, Tolerability, and Pharmacokinetics of NeuroDirect Ketamine in Healthy Adult Volunteers.” “We’re thrilled to have partnered with iNGENū as we move our proprietary delivery technology into human clinical trials. iNGENū is an industry-leading, full-service CRO providing end-to-end services for companies like ours developing psychedelic drugs. Together, we’re committed to discovering new psychedelic therapies for mental health disorders and central nervous system diseases,” said Psycheceutical CEO Chad Harman. “We’re eager to engage in this next phase of the development of ​​​​our NeuroDirect™ delivery system, which we’re designing to solve the issues with side effects that most psychedelic drug development companies face, while at the same time developing lifesaving mental health treatments.​​” ​​​The subsequent Phase II clinical trial, also with iNGENū, is targeted to involve 115 participants with PTSD and to ana...