Clinical TrialSafety & Risk ManagementPlaceboNot yet recruiting

LUCID-201-001: A Double-Blind, Single Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Lucid-201

Double-blind, randomised, single-ascending-dose Phase I study (n=48) comparing single oral ascending doses of Lucid-201 (1,2,4,6 tablets by cohort) with 100 mg niacin active placebo in healthy volunteers and patients with mild-to-moderate depressive symptoms to assess safety, PK and PD.

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

Detailed Description

Randomised, double-blind, single-ascending dose (SAD) design with six cohorts (four healthy volunteer cohorts and two cohorts of participants with mild-to-moderate depressive symptoms); n=8 per cohort randomised 6:2 (Lucid-201:niacin).

Dosing under fasting conditions with mouth checks to verify swallowing; participants remain on site for a 3 day, 2 night period for pre- and post-dose assessments with safety monitoring up to 24 hours and PK/PD sampling at multiple timepoints including 0.25–24 hr post-dose.

Safety assessments include AEs/SAEs, vital signs, ECG, clinical labs, C-SSRS, and HAM-D for cohorts 5–6; subjective effects measured by VAS at specified timepoints.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Lucid-201

experimental

Single ascending oral tablet doses of Lucid-201 by cohort (randomised vs active placebo).

Interventions

  • Compound
    via Oral• single dose• 1 doses total

    Lucid-201 tablet counts by cohort: Cohort 1 = 1 tablet; Cohort 2 = 2 tablets; Cohort 3 = 4 tablets; Cohort 4 = 6 tablets (healthy volunteers). Cohort 5 = 2 tablets; Cohort 6 = 6 tablets (patients with mild-to-moderate depressive symptoms). Dosing under fasting conditions; mouth checks to confirm swallowing.

Niacin 100 mg

active

Active placebo: oral niacin 100 mg tablet.

Interventions

  • Placebo100 mg
    via Oral• single dose• 1 doses total

    Active placebo (niacin) 100 mg.

Participants

Ages
18 – 60
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria (cohorts 1 - 4):
  • 1. Healthy male and female volunteers, 18 - 60 years of age, inclusive at the time of informed consent.
  • 2. Body mass index (BMI) within 18.0 - 32.0 kg/m2, inclusive, and minimum weight of 50 kg.
  • 3. Healthy by medical history, ECG, vitals, labs and physical examination as determined by PI/Sub-Investigator.
  • 4. QTcF ≤450 msec for males and ≤470 msec for females unless deemed otherwise by PI/Sub-Investigator.
  • 5. Systolic BP 90 - 140 mmHg and diastolic BP 40 - 90 mmHg, heart rate 40 - 100 bpm unless deemed otherwise by PI/Sub-Investigator.
  • 6. Clinical lab values within acceptable ranges or deemed not clinically significant by PI/Sub-Investigator.
  • 7. Non-smoker for at least 30 days prior to dosing.
  • 8. Capacity to give written informed consent and communicate with clinic staff.
  • 9. Ability to read/speak English sufficiently for trial assessments.
  • 10. Ability to fast for at least 13 hours and consume standard meals.
  • 11. Availability for entire trial duration and adherence to protocol.
  • 12. Agree not to have a tattoo or body piercing until end of trial.
  • 13. Agree not to receive vaccination from 7 days prior to dose until after follow-up visit.
  • 14. Agree not to drive or operate heavy machinery if impaired after dosing until recovered.
  • 15. Female participants non-pregnant and non-lactating and meet at least one contraception criterion (surgical sterilisation, post-menopausal, use effective contraception, or abstinence according to usual lifestyle).
  • 16. Male participants able to father children must use effective contraception and not donate sperm during trial and for 30 days after last dose.
  • 17. Inform site staff if partner becomes pregnant during participation and for 30 days after last dose.
  • Inclusion Criteria (Cohorts 5 and 6):
  • 1. Male and female volunteers, 18 - 60 years of age.
  • 2. BMI within 18.0 - 35.0 kg/m2 and minimum weight 50 kg.
  • 3. Presence of current depressive symptoms with HAM-D score ≥8 and <24.
  • 4. Current treatment with a single SSRI or SNRI at stable dose for ≥2 months.
  • All other inclusion criteria from Cohorts 1 - 4 apply.

Exclusion Criteria

  • Exclusion Criteria (cohorts 1 - 4):
  • 1. Known history or presence of any clinically significant systemic disease unless deemed not clinically significant by PI/Sub-Investigator.
  • 2. Clinically significant GI pathology or unresolved GI symptoms interfering with ADME within 7 days prior to dosing.
  • 3. History of seizures (including a single event) for participant or first-degree relative, history of head trauma except fully resolved minor concussions, history of neurosurgery, or first-degree relatives with idiopathic generalized epilepsy or other congenital epilepsies.
  • 4. Any clinically significant illness within 30 days prior to first dosing.
  • 5. Any significant physical or organ abnormality per PI/Sub-Investigator.
  • 6. Positive test for HIV, chronic Hepatitis B surface antigen, or Hepatitis C.
  • 7. Positive test for drugs of abuse, alcohol (breathalyzer), and/or cotinine.
  • 8. Positive pregnancy test for female participants.
  • 9. Hypersensitivity/idiosyncratic reaction to psilocybin/psilocin or related substances/excipients; significant food allergies; severe allergic reactions.
  • 10. Psychiatric exclusions: current or past schizophrenia spectrum/psychotic disorder or bipolar I/II; alcohol or drug dependence within last 2 years (excluding caffeine/nicotine); major depressive disorder, OCD, panic disorder, anorexia or bulimia within last 5 years; first-degree relative with schizophrenia spectrum/psychotic disorder or bipolar I/II; psychiatric condition incompatible with safe exposure; suicidal ideation or active suicidality based on C-SSRS.
  • 11. Intolerance to/difficulty with blood sampling.
  • 12. Use of psychedelics in past 2 years or >5 times lifetime.
  • 13. Recent blood donation >400 mL in prior 30 days or ≥500 mL in prior 56 days.
  • 14. Plasma donation by plasmapheresis within 7 days prior to dosing.
  • 15. Participation in another clinical trial or receipt of investigational drug within 30 days prior to dosing.
  • 16. Use of enzyme-modifying drugs (strong CYP inhibitors/inducers) within 30 days prior to dosing.
  • 17. Use of prescription medication within 14 days prior to dosing (except accepted contraception); topical drugs without systemic absorption may be acceptable.
  • 18. Use of OTC medications/supplements within 7 days prior to dosing (except accepted contraception); topical drugs without systemic absorption may be acceptable.
  • 19. Consumption of grapefruit/pomelo within 10 days prior to dosing.
  • 20. Consumption of caffeine/methylxanthines, poppy seeds and/or alcohol within 48 hr before dosing.
  • 21. Major surgery within 3 months prior to trial start unless deemed not clinically significant.
  • 22. Any other condition making participant unsuitable per Investigator or Sponsor.
  • 23. Difficulty swallowing tablets or capsules.
  • 24. New tattoo or piercing within 30 days prior to dosing.
  • 25. Investigator deems participant not suitable for trial.
  • Exclusion Criteria (cohorts 5 and 6):
  • 4. Presence of any clinically significant illness - except for depressive disorders - within 30 days prior to first dosing.
  • 10. Psychiatric exclusion: removal of the criterion excluding history of major depressive disorder within the last five years.
  • Additional: Presence of severe depressive symptoms (HAM-D ≥24).
  • All other exclusion criteria from Cohorts 1 - 4 apply.

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment48 participants
  • Timeline
    Start: 2023-03-15
    End: 2023-12-31
  • Compound
    Placebo
  • Topic
    Safety & Risk Management

Locations

Unknown facility — Australia

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