A Phase 1, Open-label, Single Cohort Study to... — Clinical Trial Details

This open-label Phase I study will administer a single intravenous infusion of TRP-8803 (psilocin besylate) in healthy adult participants while delivering preparatory, during-session, and integration psychotherapy by a consistent therapist dyad to evaluate safety and tolerability.

Pharmacokinetic sampling includes multiple timepoints from pre-dose through 24 hours to determine plasma concentrations and PK profile; safety monitoring includes AEs, vital signs, ECG and laboratory tests with DSMB review after first participant before dosing others.

Therapy comprises one 2-hour preparation session, the dosing session with non-directive support, and two 1-hour integration sessions (within 24 hours and at two weeks) to support meaning-making and implementation of therapeutic changes.

Participants

Ages

18 – 65

Sexes

Male & Female

BMI

20 - 30

Psychosis History

Excluded

Inclusion Criteria

Voluntary informed consent and willingness to attend follow-up visits.
Ability to receive IV medication (adequate venous access) and adhere to study regimen.
Medically stable as judged by Medical Officer/Lead Psychiatrist (screening medical exam, ECG, labs, urinalysis).
Agree to consume approximately the same amount of caffeine on session mornings as usual, or abstain if not habitual.
Agree to follow Medical Officer directions on non-prescription and prescription medications; refrain from nonprescription medications/supplements for 7 days before dosing except approved exceptions (eg paracetamol, NSAIDs, common vitamins, contraceptives).
Refrain from prescription medications for 14 days before dosing except hormonal contraceptives/HRT unless approved; no PRN meds on morning of dose.
Agree to have a support person for transport after dosing.
If required, successfully withdraw nominated medications prior to baseline.
Provide contact details for a medically qualified doctor and consent to contact.
Non- or ex-smokers and no nicotine products from 90 days prior to screening until study end.
Weight between 50 kg and 120 kg; BMI between 20 and 30 inclusive.
No psychedelic drug use in the 3 months prior to dosing and agree to refrain from non-study psychedelics during the study.
WOCBP must use two acceptable contraception methods from 30 days prior to screening until 30 days after dosing; men must avoid impregnation and sperm donation for 90 days after dosing.

Exclusion Criteria

Meets DSM-5 criteria for any psychiatric condition (including personality disorders) or other personal/situational factors judged incompatible with safe participation (eg lacking social support, unstable living situation, domestic violence, high autistic traits).
Recent (within 5 years) history of MDD, OCD, GAD, panic disorder, anorexia/bulimia, overeating disorder, PTSD, or SUD.
At screening, experiencing mild levels of depression or greater.
Recent history of suicide attempt (within 5 years) or suicidal ideation in past 6 months per C-SSRS.
History of psychosis or DSM-5 bipolar disorder, schizophrenia, or schizoaffective disorder.
Family history of psychosis (bipolar disorder, schizophrenia, schizoaffective disorder in first- or second-degree relatives).
History of alcohol abuse disorder within 1 year or regular alcohol abuse (AUDIT >8).
Meets DSM-5 criteria for substance use disorder (other than alcohol) within past 12 months or regular substance abuse (DAST-10 >3).
Currently taking or testing positive for drugs of abuse (eg amphetamines, benzodiazepines, cocaine, MDMA, opioids, synthetic cannabinoids).
Prior adverse effects from psilocybin/other psychedelics (eg severe headache or severe hypertension requiring treatment).
History of HPPD.
Serious medical condition that would interfere with safety (cardiovascular, metabolic, neurological, respiratory, oncological, haematological disorders, epilepsy/seizures).
Currently under treatment for epilepsy.
Cardiovascular conditions including uncontrolled hypertension (SBP >140 or DBP >90), angina, clinically significant ECG abnormality, recent TIA/stroke, peripheral/pulmonary vascular disease, significant QTc prolongation or conduction abnormalities.
Known conditions predisposing to hypercalcaemia, Cushing's, hypoglycaemia, SIADH, or carcinoid syndrome.
Serious abnormal haematology, electrolyte, renal or liver tests (eg AST/ALT ≥2x ULN or total bilirubin ≥1.5x ULN) unless medically cleared.
Insulin-dependent diabetes; oral hypoglycaemics excluded if history of hypoglycaemia.
Currently taking prohibited medications (eg certain antihypertensives, UGT1A9/1A10 inhibitors, aldehyde/alcohol dehydrogenase inhibitors) or antidepressants within 2 weeks (4 weeks for fluoxetine).
Serious infection requiring hospitalisation within last 28 days.

Company

Product

Legal

A Phase 1, Open-label, Single Cohort Study to Evaluate the Safety and Pharmacokinetics (PK) of a Single Intravenous (IV) Infusion of TRP-8803 [Psilocin Besylate formulation] in Healthy Adult Participants

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Therapeutic Protocol

Study Arms & Interventions

TRP-8803 IV

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details