Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05644093 | IM and IV SPL026 Drug Product in Healthy Participants | PHASE1 | COMPLETED | 14 | — | — | Jan 3, 2023 | Apr 5, 2023 | Mar 22, 2024 | 1 | United Kingdom |
| NCT05553691 | SPL026 With or Without SSRIs in Participants With MDD | PHASE1 | COMPLETED | 18 | — | — | Dec 13, 2022 | Aug 3, 2023 | Jun 14, 2024 | 2 | United Kingdom |
| NCT04673383 | SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients | PHASE1 | COMPLETED | 66 | — | — | Feb 4, 2021 | Dec 22, 2022 | Mar 27, 2024 | 2 | United Kingdom |
Values of potential clinical importance
Adverse Events (AEs)
pulse rate will be measured in bpm
arterial blood pressure
tympanic temperature
QTcX intervals
Full physical exam screening and a brief symptom guided exam at Day -1 and Day 1
The Beck Suicidal Ideation scale to monitor suicidal ideation
Adverse events (AEs)
Values of potential clinical importance
Heart rate
Blood pressure
Temperature
QTcX intervals
Columbia-Suicide Severity Rating Scale
Safety and tolerability measured by lab biochemistry, adverse events and intensity rating scale to measure tolerability of the psychedelic experience
Montgomery-Åsberg Depression Rating Scale (MADRS) score (where 7 - 19 is mild depression, 20 - 34 is moderate depression, and \>34 is severe depression) change from baseline at 2 weeks after the first dose (± 2 days)
| Arm | Type | Description |
|---|---|---|
| Psychedelic Experienced IM then IV crossover | EXPERIMENTAL | Participants will be dosed with IM SPL026 then IV SPL026 2-3 weeks later. |
| Psychedelic Naive IM dosing only | EXPERIMENTAL | Participants will be dosed with IM SPL026 one time. |
| Test Cohort | EXPERIMENTAL | Patients who are currently taking an SSRI that is not effective in fully relieving their depression (prescribed outside of study). Patients will be administered a single dose of SPL026 by intravenous infusion. |
| Control Cohort | EXPERIMENTAL | Patients who are not currently taking any pharmacological treatment for their depression. Patients will be administered a single dose of SPL026 by intravenous infusion. |
| Healthy volunteers (active) | EXPERIMENTAL | SPL026 to be administered by IV injection |
| Healthy volunteers (placebo) | EXPERIMENTAL | SPL026-matched placebo to be administered by IV injection |
| Patients (active) | EXPERIMENTAL | SPL026 to be administered by IV injection |
| Patients (placebo) | EXPERIMENTAL | SPL026-matched placebo to be administered by IV injection |
| Name | Type | Description |
|---|---|---|
| SPL026 IV | DRUG | IV dosing |
| SPL026 IM | DRUG | IM dosing |
| SPL026 | DRUG | Intravenous |
| Placebo | DRUG | SPL026-matched placebo |
Inclusion Criteria: Part A only 1. Healthy psychedelic-experienced female or male participants (psychedelic-experienced is defined as having at least 2 previous experiences, with breakthrough, of serotonergic psychedelic drugs, including but not limited to: DMT, ayahausca, LSD, LSA \[morning glory...