Safety and Psychological Effects of Psilocybin and D-Serine Formulation in Healthy Volunteers
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.
Timeline
- Start
- 2025-12-11
- Primary completion
- 2026-11
- Completion
- 2027-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | D-serine | Unknown | 5 g | Oral |
| Subject | D-serine | Unknown | 7 g | Oral |
| Subject | Psilocybin | Other / unclassified | 15 mg | Oral |
| Subject | Psilocybin | Other / unclassified | 25 mg | Oral |
Indications
No indication recorded.