Start
Completion

Dose-finding PKPD Trial for RE02 in Healthy Subjects

RecruitingRegisteredCTG

This double-blind, randomized, dose-response trial (n=15) aims to assess the pharmacokinetic and pharmacodynamic profiles of RE02, a psychedelic drug, in healthy subjects.

Details

Randomized, triple-masked crossover in healthy volunteers comparing three RE02 dose levels with a mannitol placebo across four single-dose study days, with a 6-hour intensive PK/PD assessment on each day.

Primary aims are dose–exposure characterisation and safety/tolerability; intervention embedded in a controlled setting with continuous psychological support and close adverse-event monitoring.

Topics:Healthy Volunteers

Registry

Registry linkNCT05979727