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.
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.
Cohort 1: single oral dose of psilocybin 15 mg co-administered with D-Serine 5 g.
Co-administered with D-Serine 5 g; solution form.
Cohort 2: single oral dose of psilocybin 25 mg co-administered with D-Serine 7 g (dose-escalation if cohort 1 safe).
Co-administered with D-Serine 7 g; solution form.