Entheon Biomedical Corp. announced the approval by the local Dutch ethics committee of EBRX-101, a comprehensive phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of N,N-dimethyltryptamine. The study will be conducted at the Centre for Human Drug Research, in Leiden, Netherlands, with patient screening scheduled to begin this month.

The EBRX-101 study is the core research focus of Entheon RxTM, one of the Company's business divisions, which is focused on advancing the therapeutic potential of DMT and DMT-based drug analogues. The study will use an adaptive, randomized, double-blind, placebo-controlled design with a single ascending dose of intravenous DMT to be administered via continuous-controlled infusion to a population of otherwise healthy smokers. This phase 1 study will provide Entheon with essential safety and dosing data, providing the foundation for further research of DMT's therapeutic potential.

DMT is a classic hallucinogen, similar to LSD or psilocybin in that it exerts many of its subjective, visual, and potentially therapeutic effects via the brain's serotonin system. DMT differs from the other serotonergic psychedelics in that it is naturally found in the body in trace amounts, and when given externally is rapidly metabolized, with subjective effects returning to baseline after roughly thirty minutes post- administration.