A Phase 1, Open-label, Dose-escalation Study to... — Clinical Trial Details

Participants

Ages

18 – 55

Sexes

Male & Female

BMI

20 - 30

Psychosis History

Excluded

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

TRP-8803 IV

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details