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
Visit trial
Status Completed
Results Published No
Start date 20 July 2022
End date 03 April 2023
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 48
Sex All
Age 18- 65
Therapy No

Trial Details

This is a first in human study designed to investigate the safety, tolerability and pharmacokinetics of a single dose of FT-104 HCL in healthy volunteers.

NCT Number ACTRN12622000713796

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.

Data attribution

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