Healthy Volunteers
Conditions
Keywords
healthy volunteers, 5-MeO-DMT, 5-methoxy-dimethyltryptamine
Brief summary
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.
Interventions
GH001 administered via inhalation
Sponsors
GH Research Ireland Limited
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Part A: Dose ranging in four dose groups Part B: One group with individualized dosing
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The safety and tolerability of GH001 | up to 7 days | The safety and tolerability of GH001 is judged by the Study Safety Group based on a combined analysis of reported adverse events, clinical observation, and safety laboratory analyses. |
| The dose-related psychoactive effects of GH001 as evaluated by a Visual Analogue Scale | Retrospectively assessed at 3 hours | Visual Analogue Scale scored from 0-100 |
Countries
Netherlands
Outcome results
None listed