RecruitingPhase 1

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

NCT07079930 · Hadassah Medical Organization

Recruiting

Status

Accepting participants

Phase 1

Phase

Target enrolment

Study sites

Outside the US

What it is testing

Summary

The goal of this open-label, dose-escalation, prospective study is to evaluate the safety and psychological effects of a Psilocybin and D-Serine formulation in healthy volunteers. The main objectives are: 1. To assess the psychological and physiological effects of psilocybin administered with D-Serine in healthy adults. 2. To determine whether D-Serine modulates or attenuates the psychedelic effects of psilocybin. 3. To evaluate the safety and tolerability of psilocybin and D-Serine co-administration. Study population includes: 10 healthy male or female volunteers aged 25-60 years with no history of psychiatric or major medical disorders and no current evidence of such disorders. The study includes two cohorts. The first cohort of 5 participants will receive 15 mg of Psilocybin and 5 g of D-Serine. Safety data will be collected and submitted in an interim report to the Ethics Committee. If no safety concerns arise, the second cohort will receive an increased dose of 25 mg of Psilocybin and 7 g of D-Serine to help determine the optimal dose for a future Phase IIa clinical trial.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Incidence and severity of treatment-emergent adverse events (TEAEs) following administration of psilocybin and D-serine
Measured over From time of dosing (Day 1) through Day 84 (final follow-up visit)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 60 Years

Ages

All

Sex

Accepted

Healthy volunteers

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 1 psychiatric disorder requiring pharmacotherapy such as schizophrenia, schizoaffective disorder, any other psychotic disorder, bipolar disorder, as well as non-psychotic disorders such as generalized anxiety disorder, major depressive disorder, obsessive-compulsive disorder, posttraumatic stress disorder. 2. Family history (among 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 age 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.

Where

1 study site

Facility	City	Region	Country
Hadassah Medical Organization, Jerusalem, Israel	Jerusalem	—	Israel

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07079930 on ClinicalTrials.gov →

Last updated in the registry 2026-02-05. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

All 3 trials from Hadassah Medical Organization →