Clinical TrialHealthy VolunteersNot yet recruiting

A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of a Single Intravenous Infusion of TRP-8803 (Psilocin) in Healthy Adult Participants

Phase I, open-label, non-randomised dose-escalation study (n=9) assessing safety and PK of a single 140-minute IV infusion of TRP-8803 (psilocin; 7.5, 14, or 20.5 mg) in healthy adults.

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

Detailed Description

Open-label, three-cohort ascending-dose study in healthy volunteers (3 participants per cohort) testing a single IV infusion of TRP-8803 with a 20-minute loading dose followed by a 120-minute maintenance infusion; SRC reviews PK and safety before escalation.

Participants remain onsite overnight for safety observation and PK sampling; PK timepoints include predose and 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 12, 18 and 24 hours post-start of infusion with analyses of Cmax, Tmax, t1/2, AUC0-8, AUC0-24 and AUC0-t; safety assessed via AEs/SAEs, vitals, ECG, labs, suicidality assessments and Persistent Effects Questionnaire.

Study Protocol

Preparation

sessions

Dosing

1 sessions
140 min each

Integration

sessions

Study Arms & Interventions

TRP-8803 IV

experimental

Three-cohort, open-label, single-dose IV infusion of TRP-8803 (psilocin) with dose escalation and Safety Review Committee assessments between cohorts.

Interventions

  • Compound7.5 mg
    via IV• single dose• 1 doses total

    Cohort 1: total 7.5 mg (loading 1.5 mg over 20 min, then 6 mg over 120 min; ~0.05 mg/min).

  • Compound14 mg
    via IV• single dose• 1 doses total

    Cohort 2: total 14 mg (loading 3.0 mg over 20 min, then 11 mg over 120 min; ~0.10 mg/min).

  • Compound20.5 mg
    via IV• single dose• 1 doses total

    Cohort 3: total 20.5 mg (loading 4.5 mg over 20 min, then 16 mg over 120 min; ~0.15 mg/min).

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • 1. Overtly healthy and medically stable by PI judgment (screening medical history, physical exam, ECG, no clinically significant labs).
  • 2. Male and female, 18–55 years inclusive at consent.
  • 3. Weight 50–120 kg inclusive; BMI 20–30 inclusive.
  • 4. Capable of giving signed informed consent and complying with protocol/ICF.
  • 5. Adequate venous access for IV administration and PK sampling.
  • 6. Contraception requirements for WOCBP and male participants as specified (women must use 2 acceptable methods from 30 days prior to screening until 30 days after dose; men must avoid impregnation and sperm donation for 90 days after dose).
  • 7. WOCBP: negative serum pregnancy at screening and negative urine pregnancy at baseline and on dose day.
  • 8. Refrain from legal psychoactive substances (except caffeine as specified); non- or ex-smokers or limited nicotine use with negative cotinine.
  • 9. Alcohol abstinence for 72 hours prior to dosing.
  • 10. No psychedelic drug use in prior 3 months and agree to refrain during study.
  • 11. Abstain from nonprescription supplements/medications for 7 days before dose (and 14 days for prescription meds except hormonal contraceptives) unless approved.
  • 12. If caffeine consumer, stop caffeine 48 hours before dosing and during confinement.

Exclusion Criteria

  • 1. Current DSM-5 psychiatric condition by MINI.
  • 2. Prior primary psychotic disorder, bipolar I/II, or schizophrenia (unless substance-induced/medical).
  • 3. Recent or concurrent major depressive disorder, OCD, GAD, panic disorder, eating disorders, PTSD, or substance use disorder within specified windows.
  • 4. First-degree family history of primary psychotic disorder, bipolar I/II, or schizophrenia.
  • 5. Recent history of suicide attempt within past 5 years or suicidal ideation in past 6 months (positive response to Question 4 or 5 of C-SSRS at screening).
  • 6. History of alcohol abuse disorder within 1 year or regular alcohol abuse within 3 months.
  • 7. DSM-5 substance use disorder (other than alcohol) within past 12 months.
  • 8. Vital signs: SBP >160 mmHg, DBP >95 mmHg, HR >100 bpm on 2+ readings.
  • 9. Significant cardiovascular conditions or ECG abnormalities (QTc >470 ms women / >450 ms men, PR >220 ms, QRS >120 ms, etc.).
  • 10. Currently treated for epilepsy.
  • 11. Liver function >1.5×ULN or eGFR <60 mL/min.
  • 12. Current use or positive test for drugs of abuse; prohibited medications (including specific enzyme inhibitors) within defined windows.
  • 13. Prior adverse effects from psilocybin/psychedelics.
  • 14. Currently taking prohibited medications within 5 half-lives of Dose Day.
  • 15. Antidepressant use within specified windows (2 weeks or 4 weeks for fluoxetine).
  • 16. Participation in another clinical study or investigational product within 30 days or 5 half-lives as specified.
  • 17. Any other investigator-determined unsuitability.
  • 18. Pregnant, lactating, or planning pregnancy during study.
  • 19. Unwilling to withhold prohibited concomitant medications.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment9 participants
  • Timeline
    Start: 2024-05-24
    End: 2025-05-24
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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