Entheon Biomedical Corp. announced that the first patient has been enrolled in the EBRX-101 study, a comprehensive phase I clinical trial evaluating the pharmacokinetics, pharmacodynamics and safety profile of N, N-dimethyltryptamine (DMT). The Company enrolled the first EBRX-101 study patient following successful site initiation and patient recruitment.
The first patient has been admitted into the [research] clinic for observation and preliminary testing, with dosing to occur the following day. After dosing, the patient will remain in the clinic overnight for evaluation and monitoring. Recruitment and screening of additional study participants continues, and the Company expects full enrollment of its first study cohort in short order.
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.
The study is being conducted at the Centre for Human Drug Research, in Leiden, the Netherlands.