Cybin has received approval from the Institutional Review Board (IRB) at the University of the West Indies Hospital in Jamaica for a Phase II trial of its psilocybin formulation, CYB001, to treat major depressive disorder (MDD).
This Phase II trial will assess Cybin’s sublingual psilocybin formulation versus a 25mg psilocybin capsule. A Phase IIa study will enrol 40 patients to determine the bio-equivalent dose of CYB001 when compared to a 25mg capsule.
Topic Depression
Country Jamaica
Visit trial
Status
Planned
Results Published
Start date
01 December 2021
End date
01 June 2023
Chance of happening
90%
Phase
Phase II
Design
Open
Type
Interventional
Generation
Second
Participants
50
Sex
All
Age
18- 99
Therapy
No
Trial Details
This Phase II trial will assess Cybin’s sublingual psilocybin formulation versus a 25mg psilocybin capsule. A Phase IIa study will enrol 40 patients to determine the bio-equivalent dose of CYB001 when compared to a 25mg capsule.NCT Number
Sponsors & Collaborators
CybinCybin is a for-profit company that aims to deliver psychedelics (psilocybin) via a sublingual delivery mechanism. The company aims to start clinical trials within the year (2021). It has raised $98 million US.