LUCID-201-001: A Double-Blind, Single Ascending... — Clinical Trial Details

Participants

Ages

18 – 60

Sexes

Male & Female

BMI

18 - 35

Psychosis History

Excluded

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.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Study Arms & Interventions

Lucid-201

Interventions

Niacin 100 mg

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details