A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers Safety, Tolerability, and Pharmacokinetics of Subcutaneous FT-104 HCl (SAIL-101)

This double-blind, randomized, placebo-controlled study (n=48) investigates the safety, tolerability, and pharmacokinetics of single, ascending, subcutaneous doses of psilocybin (FT-104 HCl) in healthy volunteers.

The trial involves up to six cohorts, each with eight participants, where six receive FT-104 HCl and two receive a placebo. Doses range from 5.5 mg to a maximum of 52.7 mg, with cohorts planned to receive different doses. Adverse event data will be collected throughout the study period, and safety laboratory tests, vital sign assessments, and ECG measurements will be conducted at various time points.

The primary outcome is the occurrence of adverse events, while the secondary outcome focuses on investigating the pharmacokinetic properties of the drug.

Recruitment for the study was completed in March 2023, with Field Trip Psychedelics Inc. and Beyond Drug Development Pty Ltd providing funding. The study is led by Principal Investigator Prof Guy Ludbrook at the Royal Adelaide Hospital in Australia.

Topic Healthy Subjects
Compound Placebo Psilocybin
Country Australia Canada
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Trial Details



Trial Number

Sponsors & Collaborators

Field Trip (PD)
Field Trip offers ketamine infusions for treatment-resistant depression in the US (NY, LA) and Canada (Toronto). The offering is polished, yet still somewhat pricey.

Papers

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study
This double-blind, randomised, placebo-controlled Phase I study (n=48) evaluates the safety, pharmacokinetics, and psychoactive effects of RE104 (psilocybin analog; Luvesilocin; a prodrug of 4-OH-DiPT) in healthy adults with prior psychedelic experience. RE104 was well tolerated up to 40 mg with no serious adverse events, and plasma levels of its active form correlated with subjective drug effect and mystical experience scores. The compound produced psilocybin-like effects with a shorter duration (3–4 hours), supporting further therapeutic investigation.

Data attribution

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