CompletedPhase 1DMT

Safety of GH001 in Healthy Volunteers

NCT ID

NCT04640831

Target Enrollment

22 participants

Start Date

2019-03-13

Est. Completion

2019-10-04

About This Study

The aim of the study is to investigate the safety of GH001 (containing 5-methoxy-dimethyltryptamine; 5-MeO-DMT), and its dose-related psychoactive effects in healthy volunteers. The study will evaluate single, ascending doses of GH001 in Part A and an individualized dosing regimen of GH001 in Part B.

Conditions Studied

Healthy Volunteers

Interventions

•5 Methoxy N,N Dimethyltryptamine

Eligibility

Age:18 Years - 45 Years

Healthy Volunteers:Yes

View full eligibility criteria

Inclusion Criteria:

* Subject has a body mass index (BMI) in the range of 18.5 and 27.0 kg/m2 (inclusive);
* Subject is in good general health in the opinion of the medical supervisor;
* Subject is in good mental health in the opinion of the (clinical) psychologist as determined by the intake interview;

Exclusion Criteria:

* Has known allergies or hypersensitivity or any other contraindication to 5-MeO-DMT;
* Has received any investigational medication within the last 1 month.
* Has a medically significant condition, which renders the subject unsuitable for the study.

Study Locations (1)

Clinical Trial Site