Safety and Pharmacokinetics of GH002 in Healthy Volunteers

Adverse events reported in the study and coded by MedDRA.

Local infusion site findings will be assessed as none, mild, moderate and severe for the following signs and symptoms of the applicable site: dryness, redness, swelling, pain, tenderness, and itching and other.

Clinically significant changes in ECG include any significant change in rate or rhythm as determined by the principal investigator

The Modified Observer's Assessment of Alertness and Sedation scale (MOAA/S) will be completed before and after GH002 dosing. Scored from 0 (deep sedation) to 5 (alert)

The CADSS comprises 19 subjective items, ranging from 0 'not at all' to 4 'extremely. Summed together, these subscales form a total dissociative score. Combined score ranges from 0 to 76

Assessment of Discharge Readiness on the administration day by the Principal Investigator, using the Clinical Assessment of Discharge Readiness (CADR).

A detailed questionnaire assessing both suicidal behaviour and suicidal ideation.

A scale to measure psychiatric symptoms. Each symptom is rated 1-7 and a total of 18 symptoms are scored. Combined score ranges from 18 to 126.

For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH002 to determine 5-MeO-DMT serum concentrations.

The Peak Experience Scale (PES) is a Visual Analogue Scale scored from 0-100

Completed by the subject after GH002 administration and assesses seven factors (grief, fear, death, insanity, isolation, physical distress, and paranoia) all scored from 0 to 5.

The MEQ30 is a validated procedure for assessing the extent of the psychoactive effects experienced by a subject. The validated MEQ30 uses thirty assessment questions across four areas of experience, all scored from 0 to 5.

The duration of the experience, defined as time in minutes from drug administration to time when the subject reports that any psychoactive symptoms have subsided will be recorded.

In particular the correlation between Cmax and AUC with PES score and duration of PsE as scored by the investigator will be described

A computerized test assessing the reaction time in response to a visual stimulus.

The VRM test is based on successive auditory presentations of 18-word lists followed by attempted recall.

The SWM test requires retention and manipulation of visuospatial information. This test has notable executive function demands, and measures strategy use as well as errors. In this task the subject has to search for tokens hidden in boxes on screen. The subject must touch a box to open the box to reveal either a yellow token or an empty box. Once the subject has found a yellow token, they must touch the outline of the right-hand side of the screen to 'store' it. The subject must then continue searching through the boxes until all of the tokens have been found. The test takes about 4 minutes to complete

The DSST is a global measure of cognitive ability, requiring the engagement of multiple cognitive domains in order to complete effectively. A computerized test with the task is to match digits with symbols from encoding list. The number of digits correctly encoded within 90 seconds is the performance measure.

For PK analyses, blood samples will be collected before and up to 6 hours after the administration of GH002 to determine bufotenine serum concentrations.