The first patient has now been enrolled on to the Entheon Biomedical Phase 1 Study of DMT.
The EBRX-101 study is aiming to investigate the pharmacokinetics, pharmacodynamics and safety profile of DMT. The trial will be the basis for future Phase II trial exploring the efficacy of DMT for smoking cessation and the treatment of other substance addictions.
Successful enrolment of the first patient followed site initiation and patient recruitment. The patient has now 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.
CEO of Entheon, Timothy Ko, commented: “The enrolment and imminent dosing of the first patient in Entheon’s Phase 1 study of DMT begins the active research phase of Entheon’s core clinical programme.
“In our view, this is a monumental occasion, marking the start of the formal clinical stage of Entheon’s development of DMT as a treatment for addiction disorders.”
The company received approval from the Dutch ethics committee for the trial in February 2022. The EBRX-101 study is the core research focus of Entheon Rx™, one of the Entheon Biomedical’s business divisions, which is focused on advancing the therapeutic potential of DMT and DMT-based drug analogues.
It will use an adaptive, randomised, 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.
The company says the recruitment and screening of additional study participants continues, and that it expects full enrolment of its first study cohort soon.
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