Clinical TrialHealthy VolunteersPsilocybinPlaceboCompleted

A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers Safety, Tolerability, and Pharmacokinetics of Subcutaneous FT-104 HCl (SAIL-101)

Double-blind, randomised, placebo-controlled single-ascending subcutaneous dose PK and safety study in healthy volunteers (n≈48; cohorts of 8, 6 active + 2 placebo) of FT-104 HCl (psilocybin formulation).

Target Enrollment
48 participants
Study Type
Phase I interventional
Design
Randomized, single Blind

Detailed Description

Phase I, cohort-based, single-ascending dose study of subcutaneous FT-104 HCl in healthy volunteers with up to six cohorts (each up to 8 participants; sentinel dosing and Safety Review Committee–managed escalation).

Primary endpoints are safety, tolerability and PK (Cmax, Tmax, AUCs, t1/2) with intensive sampling through 24 hours and a follow-up visit at Day 10. Safety monitoring includes AEs/SAEs, vitals, ECG, labs and injection-site assessments; suicidality monitored using C-SSRS.

Study Protocol

Preparation

sessions

Dosing

1 sessions
1440 min each

Integration

sessions

Study Arms & Interventions

FT-104 HCl (subcutaneous)

experimental

Single-ascending subcutaneous doses across up to 6 cohorts (sentinel dosing, cohort escalation by Safety Review Committee).

Interventions

  • Psilocybin5.5 - 52.7 mg
    via Subcutaneous• single dose• 1 doses total

    Cohorts: 5.5, 11, 22, 33, optionally 44 and 38 mg; highest evaluable 52.7 mg; sentinels (1 active, 1 placebo) used in all cohorts.

Placebo (saline)

inactive

Normal saline (0.9% sodium chloride) subcutaneous injection; ~2 placebo per cohort.

Interventions

  • Placebo
    via Subcutaneous• single dose• 1 doses total

    Normal saline 0.9%

Participants

Ages
18 – 65
Sexes
Male & Female

Inclusion Criteria

  • 1. Signed informed consent in a language understandable to the subject prior to any study-related procedure.
  • 2. The subject has at least one prior recreational experience with hallucinogenic or psychedelic compounds.
  • 3. The subject weighs at least 60kg and has a BMI between 18 - 30 kg/m2.
  • 4. Women of childbearing potential (WOCBP) must be non-lactating and have a negative pregnancy test. Females who are not WOCBP must be either surgically sterile or post-menopausal.
  • 5. In the opinion of the investigator, the subject is capable of understanding and is willing and able to comply with all conditions and requirements of the study.

Exclusion Criteria

  • 1. Subject has current or a history of any clinically significant illness which may affect safety, or potentially confound the study results.
  • 2. Subject has current or a history of clinically significant mental disorders as assessed by questionnaire and interview by a qualified medical personnel professional at screening.
  • 3. Subject has a risk of suicide per the Columbia-Suicide Severity Rating Scale (C-SSRS) or has a history of suicidal ideation or suicidal behavior.
  • 4. Immediate (1st degree) blood-related family members, or personal currently or previously diagnosed with psychotic or bipolar disorder.
  • 5. Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks prior to screening.
  • 6. Subject has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to screening.
  • 7. Previous major adverse response to a hallucinogenic or psychedelic drug, as determined by the qualified/trained investigator.
  • 8. Use of ayahuasca, kambó, yopo, ibogaine, psilocybin, dimethyltryptamine (DMT), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), lysergic acid diethylamide (LSD), Syrian Rue, or other psychedelic agents or mixtures in their synthetic or naturally-occurring form, and use of amphetamines, opioids, or 3,4-Methylenedioxymethamphetamine (MDMA), in the 90 days before screening and through to EOS/ET.
  • 9. Use of synthetic or naturally-occurring cannabinoids from 28 days prior to study drug administration and agree not to use through to EOS/ET.
  • 10. Subject has a positive cotinine at screening or on Day -1.
  • 11. Positive alcohol breath test or urine screen for drugs of abuse at screening or on Day -1.
  • 12. Subject has a history of drug abuse.
  • 13. Excessive alcohol consumption.
  • 14. Consumption of products containing caffeine, xanthine or poppy seeds from 48 hours prior to study drug administration until last PK sample had been collected.
  • 15. Participation in another clinical study involving study treatment within 30 days or 5 half-lives, whichever is longer, prior to screening.
  • 16. Administration of any vaccine within 28 days prior to study drug administration and through to EOS/ET.
  • 17. Use of any psychoactive medication (e.g., a selective serotonin reuptake inhibitor such as paroxetine or citalopram) haloperidol or a medication with monoamine oxidase (MAO) activity (such as isocarboxazid, phenelzine, selegiline or tranylcypromine, linezolid, and methylene blue) within 28 days prior to study drug administration and through to EOS/ET.
  • 18. Any positive results for serum hepatitis B surface antigen (HbsAg), hepatitis C antibody and human immunodeficiency virus (HIV) at screening.
  • 19. Resting (for at least 5 minutes) systolic blood pressure > 140 or < 90 mmHg or resting diastolic blood pressure > 90 or < 40 mmHg; Resting (for at least 5 minutes) pulse rate outside the range of < 40 or > 100 beats/min at screening or at any time point prior to study drug administration.
  • 20. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting electrocardiogram (ECG).

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedsingle Blind
  • Target Enrollment48 participants
  • Timeline
    Start: 2022-07-20
    End: 2023-04-03
  • Compounds
    PsilocybinPlacebo
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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