The first patient has been dosed in Small Pharma’s Phase I study that is comparing the profiles of the company’s proprietary formulation of DMT.
Small Pharma states that the goal of the study is to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of SPL026 delivered via IM versus IV administration.
Up to 14 healthy volunteers will take part in the study that will be conducted at Hammersmith Medicines Research Ltd. in the United Kingdom.
Chief Medical and Scientific Officer, Dr Carol Routledge, said: “IM injection of SPL026 may provide greater convenience for physicians, as well as potentially improve the treatment experience for some patients.
“This study seeks to identify a target dose of SPL026, administered via IM injection, that is well tolerated and delivers a consistent breakthrough psychedelic experience.
“By understanding parameters such as the duration and intensity of the psychedelic experience, we will be able to explore the potential application of IM SPL026 for treating mental health conditions.”
CEO, George Tziras, added: “Patient access is core to our mission. It is reflected in our decision to focus on short-duration psychedelics delivered through different administration routes, with the goal of maximising patient reach and convenience.
“With the Phase 2a study of IV SPL026 in Major Depressive Disorder now completed, and results anticipated very soon, we are a step closer to understanding the potential efficacy of SPL026 as a depression treatment.
“These proof-of-concept results, combined with the results of our other SPL026 studies, will help guide our future clinical development and commercialisation strategy.”
