Dose-finding PKPD Trial for RE02 in Healthy Subjects

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.

Conducted by Reconnect Labs, the study involves participants undergoing four study days with varying doses of RE02 and a placebo, with continuous psychological support.

Pharmacokinetic and pharmacodynamic assessments are conducted over six hours on each study visit to estimate the dose-exposure relationship and potential drug-drug interactions. Adverse events are closely monitored throughout the study.

The primary completion of the trial is estimated to have occurred in December 2023, with the study anticipated to be completed by January 2024. Eligible participants are required to be experienced with psychedelic substances and must be willing to comply with study requirements. The study is being conducted at the University Hospital of Psychiatry Zurich, Switzerland.

Topic Healthy Subjects
Compound Placebo 5-MeO-DMT
Country Switzerland
Visit trial
Status Recruiting
Results Published No
Start date 20 November 2023
End date 31 January 2024
Chance of happening 100%
Phase Phase I
Design Blinded
Type Interventional
Generation Second
Participants 15
Sex All
Age 25- 45
Therapy Yes

Trial Details

The goal of this clinical trial is to compare corresponding inter- and intraindividual pharmacokinetic and pharmacodynamic profiles including assessments of safety & tolerability of three different doses against a placebo control.

NCT Number NCT05979727

Sponsors & Collaborators

Reconnect Labs
Reconnect Labs, a Swiss-based clinical-stage pharmaceutical company, is pioneering the development of Regenerative Therapeutics™ aimed at mental health, leveraging cutting-edge neuroscience and precision psychopharmacology.

University of Zurich
Within the Department of Psychiatry, Psychotherapy and Psychosomatics at the University of Zurich, Dr Mialn Scheidegger is leading team conducting psychedelic research and therapy development.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.