The goal of the study is to establish the safety of TRP-8803 in humans, which will inform the Phase IIa patient study pipeline.
Tryptamine Therapeutics has announced the dosing of the first subject in a clinical trial of TRP-8803, an intravenously (IV)-infused psilocin, in Adelaide, South Australia.
The first participant received TRP-8803 for approximately 140 minutes and completed the treatment without any issues. Following a post-dosing follow-up, the participant was safely discharged.
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Dubbed the Healthy Human Volunteer Study, the trial is being conducted by CMAX Clinical Research, aiming to refine dosing and infusion rates for precise blood levels of psilocin as a psychedelic treatment.
It seeks to optimise the pharmacokinetics profile of TRP-8803 in up to 12 participants.
The goal is to establish the safety of TRP-8803 in humans, which will inform the Phase IIa patient study pipeline.
The study will also prepare for additional clinical trials targeting specific need states.
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According to the company, the potential benefits of IV-infused psilocin solution include faster onset, more precise control of the psychedelic experience, and a shorter duration of the intervention.
A lead programme of Tryp, TRP-8803 is set to address several limitations of oral psilocybin therapy.
The company plans to continue the trial with additional participants and expects to receive interim results by the third quarter of this year.
Positive outcomes from this study could significantly advance Tryp’s clinical trial pipeline across various conditions.
Tryp CEO Jason Carroll said: “Pleasingly, the maiden participant was delivered the infusion safely and was discharged on treatment conclusion, which provides management with confidence of TRP-8803 and the completion of this Healthy Human Volunteer Study.
“The trial, which being undertaken alongside CMAX is an incredibly important initiative for Tryp, as it will provide us with data highlighting TRP-8803’s safety in humans at escalating doses. This will form the basis of the company’s clinical trial pipeline into other indications and ultimately our regulatory engagement.”
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Tryptamine doses first subject in IV-infused psilocin trial – Clinical Trials Arena
