Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers

A single administration of the drug, with dosage divided as follows:

Cohort 1: 15 mg of Psilocybin and 5 gr of D-Serine Cohort 2: 25 mg of Psilocybin and 7 gr of D-Serine

The physical examination will include diagnosis and documentation of any significant clinical abnormalities or diseases. It will be performed during the baseline rating visit (preparation phase).

Vital sign measurements (blood pressure, pulse, and oxygen saturation) will be taken at screening, preparation, baseline rating, administration day, day 2, day 28, and day 84.

Vital signs will be assessed at the following time points on the administration day and on day 2: pre-administration, and at 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, and 24 hours post-administration.

A 12-lead ECG will be performed to rule out underlying cardiac abnormalities. An ECG will be conducted for each patient during the screening and Day 2 visits.

A comprehensive blood panel will be performed to assess kidney and liver function, electrolyte balance, and glucose levels.

It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.

Complete Blood Count will be performed to check for hematological abnormalities.

It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.

Urinalysis will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.

Urine Toxicology Screen will be performed to rule out illicit drug use. It will be conducted during the Screening visit, and on Day 2, Day 28, and Day 84.

A urine pregnancy test will be performed for women of childbearing potential only. It will be conducted during the screening and baseline rating visits. If the urine test is positive, a serum β-hCG test will be performed for confirmation.

EEG will be performed during the baseline rating scale and Day 7 visits to evaluate brain activity

The following blood test parameters - D-Serine, L-Serine, and Glycine - will be assessed during the Screening and Day 28 visits.

The following blood test parameters - Tumor Necrosis Factor Alpha (TNF-α), Interleukin-6 (IL-6), and C-Reactive Protein (CRP) - will be assessed during the Screening and Day 28 visits.

Plasma BDNF (Brain-Derived Neurotrophic Factor) levels will be measured during the screening and Day 28 visits.

The Mini International Neuropsychiatric Interview (MINI) will be administered during the screening visit to rule out any current or past major psychiatric disorders.

The Family Psychiatric History Assessment (FPHA) will be administered during the screening visit to help rule out any current or past major psychiatric disorders.

The Beck Depression Inventory (BDI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to assess baseline mood and to rule out depressive symptoms.

State-Trait Anxiety Inventory (STAI) will be administered at the following visits: screening, baseline, day 7, day 28, and day 84. It will be used to screen for anxiety disorders.

The Profile of Mood States (POMS) will be administered to assess baseline mood and emotional state.

It will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.

On the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.

Subjective Units of Distress Scale (SUDS) will be administered to assess anxiety and stress levels.

It will be administered at the following visits: screening, baseline, administration day, day 2, day 7, day 28, and day 84.

On the administration day and on day 2, it will be administered at the following time points: pre-administration, and 8 and 20 hours post-administration.

The Five-Dimensional Altered States of Consciousness questionnaire (5D-ASC) will be used to assess the acute subjective psychedelic experience. It will be administered after the acute effects have subsided - at 6.0 hours post-administration on the administration day, and again on day 2 - to evaluate five key experiential dimensions: visual restructuralization, oceanic boundlessness, reduction of vigilance, anxious ego dissolution, and auditory alterations. Each item will be rated using a Visual Analogue Scale (VAS) ranging from "NO, not more than usually" (0 mm) to "YES, much more than usually" (100 mm).

The integration process is conducted to support participants in processing and incorporating their therapeutic experience into daily life, with the aim of enhancing emotional insight and psychological well-being. Integration will take place at the following visits: 8.0 hours post-treatment on the administration day, day 2, day 7, day 28, and day 84.