A Phase 1 Randomized, First-in-Human,... — Clinical Trial Details

Participants

Ages

18 – 55

Sexes

Male & Female

BMI

18 - 32

Psychosis History

Excluded

Inclusion Criteria

Each participant must meet all the following criteria to be enrolled in this study:
1. Male or female aged between 18 and 55 years of age, inclusive, at time of consent.
2. Female participants must have a negative serum pregnancy test result at Screening (all cohorts) and Day 8 (Cohort 2 only), and a negative urine pregnancy test at admission to the CRU on Day -1 (all cohorts), are not currently breast-feeding, and meet one of the following criteria: a) undergone a sterilization procedure ≥6 months before first dosing; b) be postmenopausal with amenorrhea ≥1 year and FSH consistent with postmenopausal status; c) WOCBP must use at least one protocol-specified effective/ highly effective method of birth control AND agree to use barrier contraception (male condom) during heterosexual intercourse from Screening until at least 90 days after EMP-01 administration. Complete abstinence is acceptable but pregnancy testing continues per protocol.
3. Male participants must agree to use double barrier contraception or sexual abstinence and not donate sperm from consent until 120 days after EMP-01 administration (contraceptive requirements not applicable to participants exclusively in same-sex relationships unless they become heterosexual).
4. Judged to be in good health based on medical history, physical exam, vitals and safety labs at screening and prior to first dose.
5. Participant weight ≥45 kg and ≤100 kg and BMI between 18.0 and 32.0 kg/m2 inclusive at Screening.
6. Agrees to be available for all study visits and cooperate with protocol requirements.
7. Participants who smoke ≤2 cigarettes/pipes/cigars/e-cigarettes or equivalent per week from 3 months prior to Screening may be included and must abstain from smoking/nicotine for 24 hours prior to IP administration and during CRU confinement.
8. Capable of using common smartphone applications.
9. Willing to have psychiatric screening, dosing session, and integration session audio recorded.
10. Willing and able to provide written informed consent.

Exclusion Criteria

Participants who meet any of the following criteria will be excluded:
1. Known allergy or hypersensitivity to MDMA or any excipients.
2. History of cardiovascular, cerebrovascular, or peripheral vascular disease (eg unstable angina, MI, CHF, arrhythmia, hypertension/hypotension, bradycardia, tachycardia).
3. Clinically significant vital signs at Screening (SBP <80 or >140 mmHg; DBP <40 or >90 mmHg; RR <10 or >22), with confirmation repeats allowed per PI.
4. Past or current significant mental, behavioural, or neurodevelopmental disorder per DSM-5 as assessed by MINI, including schizophrenia, schizotypal, delusional disorders, current mood (affective) disorders, neurotic/stress-related/somatoform disorders, or personality disorders.
5. Family (first degree) history of psychotic disorders such as bipolar disorder, schizophrenia, or depression with psychotic features.
6. Current suicidal ideation as assessed by the C-SSRS up to 1 month prior to Screening; lifetime history may be excluded at PI discretion.
7. History of >25 lifetime administrations of psychedelic drugs or MDMA, or last use of a psychedelic or MDMA within 6 months prior to Screening.
8. History of seizures or convulsions (except pediatric febrile seizures) or raised intracranial pressure.
9. Active malignancy or history of malignancy within 2 years (excluding basal/squamous cell carcinoma).
10. Clinically significant ECG findings at Screening as judged by PI (eg HR <40 or >100 bpm; QTcF >450 ms males or >470 ms females; QRS >120 ms; PR >220 ms), with repeats allowed for confirmation.
11. Clinically significant lab abnormalities at Screening (eg Hb <=130 g/L males or <=115 g/L females; ALT/AST >1.5×ULN or bilirubin >2×ULN; estimated creatinine clearance <80 mL/min). Abnormal labs may be retested once to confirm.
12. History of alcohol use disorder defined as average weekly intake >21 drinks (males) or >14 drinks (females) within 5 years prior to Screening.
13. History of substance use disorder or dependency within 5 years, recreational IV drug use within 5 years, or positive tox screen (including MDMA/THC/amphetamines/opiates/etc) or positive alcohol breath test at Screening or prior to dosing.
14. Positive serology (HBsAg or confirmed HCV) and/or positive HIV antibody/p24 antigen screen.
15. Unwilling to refrain from systemic or topical medications (including herbal supplements) taken within 5× elimination half-life of the IP or within 14 days of IP administration, whichever is longer; or medications that chronically alter drug absorption/elimination within 30 days; or slow-release formulations within 14 days unless judged non-interfering by PI/Sponsor.

Company

Product

Legal

A Phase 1 Randomized, First-in-Human, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Ascending Doses of EMP-01 in Healthy Adult Volunteers

Detailed Description

Study Arms & Interventions

EMP-01

Interventions

Placebo

Locations

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details