Mind Medicine (NASDAQ: MNMD) (NEO:MMED) announced the first patient has ben dosed in a Phase 1 investigator-initiated study led by MindMed collaborator Prof. Dr. Matthias Liechti at University Hospital Basel (UHB). The study aims to evaluate the effects of MDMA-like substances, including MDA, Lys-MDMA, Lys-MDA, versus a placebo in healthy volunteers.
Prof. Matthias Liechti commented on the study:
“Although amphetamines like MDMA and MDA induce mainly positive subjective and mood-enhancing effects, they may also produce negative subjective drug effects, particularly at the onset of response. Lys-MDMA and Lys-MDA are prodrugs that are slowly metabolized to MDMA and MDA, offering a novel and controlled delivery system of these active substances with potentially improved pharmacological properties. By using pharmacokinetics and modern psychological and psychometric tests, this study will investigate the potential to better control the bioavailability, slow the effect onset and reduce possible adverse effects of MDMA and MDA by using these prodrugs. The study will also investigate effects of MDA in direct comparison with MDMA for the first time in humans.”
The Phase 1 clinical trial is a randomized, placebo-controlled, double-blinded, 5-period crossover study. The trial plans to enroll 24 healthy subjects who will receive MDA (100mg), MDA (93.9mg), Lys-MDMA (171.7 mg), Lys-MDA (165.6 mg), and placebo. The primary outcome measures for this study will assess acute subjective effects using Visual Analog Scales (VAS) assessing the intensity and duration of subjective effects on a scale (0-100 percent) with higher scores representing more intense effects as well as plasma levels of MDMA and MDA at each study day across the 18-month study period.
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