Clinical TrialHealthy VolunteersPsilocybinPsilocybinRecruiting

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

This Phase I, open-label, dose-escalation trial (n=10) will evaluate the safety and psychological effects of a combined psilocybin and D-Serine formulation; cohort 1 will receive psilocybin 15 mg with D-Serine 5 g, and if safe cohort 2 will receive psilocybin 25 mg with D-Serine 7 g.

Target Enrollment
10 participants
Study Type
Phase I interventional
Design
Non-randomized

Detailed Description

Open-label, first-in-human Phase I study in healthy volunteers to evaluate safety, tolerability and initial psychological and physiological effects of a single oral administration of psilocybin combined with D-Serine.

Preclinical evidence suggests D-Serine, an NMDA co-agonist, may attenuate acute psychedelic effects of psilocybin while enhancing markers of synaptic plasticity; the study will test this combination's safety and signal on biological and subjective measures.

Study uses a sequential two-cohort dose-escalation design (cohort 1: psilocybin 15 mg + D-Serine 5 g; cohort 2: psilocybin 25 mg + D-Serine 7 g) with interim safety review between cohorts and follow-up visits on Day 2, 7, 28 and 84.

Safety and outcome assessments include vital signs, ECG, laboratory panels, EEG, plasma amino acids, inflammation markers, BDNF, AE/SAE monitoring, and psychometric instruments (BDI, STAI, POMS, SUDS, 5D-ASC), plus integration support.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

5 sessions

Study Arms & Interventions

Psilocybin 15 mg + D-Serine 5 g

experimental

Cohort 1: single oral dose of psilocybin 15 mg co-administered with D-Serine 5 g.

Interventions

  • Psilocybin15 mg
    via Oral• single dose• 1 doses total

    Co-administered with D-Serine 5 g; solution form.

Psilocybin 25 mg + D-Serine 7 g

experimental

Cohort 2: single oral dose of psilocybin 25 mg co-administered with D-Serine 7 g (dose-escalation if cohort 1 safe).

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    Co-administered with D-Serine 7 g; solution form.

Participants

Ages
25 – 60
Sexes
Male & Female

Inclusion Criteria

  • 1. Aged 25-60 years, male or female.
  • 2. Medically healthy, as confirmed by a comprehensive clinical assessment.
  • 3. Written informed consent provided.

Exclusion Criteria

  • 1. History of any Axis I psychiatric disorder requiring pharmacotherapy (including schizophrenia, schizoaffective disorder, other psychotic disorders, bipolar disorder, major depressive disorder, generalized anxiety disorder, OCD, PTSD).
  • 2. Family history (first-degree relatives) of schizophrenia, bipolar disorder, or other psychotic disorder.
  • 3. History of cardiovascular disorders.
  • 4. Pregnant or breastfeeding women or women of childbearing potential not using effective contraception.
  • 5. Use of psilocybin or other psychedelic compound in the 12 months preceding the study.
  • 6. Use of medications that interact with psilocybin or D-Serine.
  • 7. Positive urinary drug screening.

Study Details

  • Status
    Recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment10 participants
  • Timeline
    Start: 2025-11-01
    End: 2027-02-01
  • Compounds
    PsilocybinPsilocybin
  • Topic
    Healthy Volunteers

Locations

Hadassah Medical Organization, Jerusalem, Israel — Jerusalem, Israel

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