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Also known as SPL026 IV, DMT, dimethyltryptamine
SPL026 · 3 trials · 1 indication
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...
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SPL026 is being developed for the treatment of major depressive disorder. It is an investigational small molecule studied in Phase 1 clinical trials conducted in the United Kingdom, including studies in healthy volunteers and in participants with major depressive disorder.
SPL026 is being developed by Cybin Inc., which trades under the ticker HELP. The company has sponsored three completed Phase 1 clinical trials of the drug in the United Kingdom, evaluating it in healthy participants and in patients with major depressive disorder.
SPL026 is in Phase 1 clinical development. Three Phase 1 trials have been completed, and no later-stage trials are currently active. The drug remains investigational and has not been approved for any indication.
SPL026 has been studied in three completed Phase 1 trials: NCT04673383 in healthy subjects and MDD patients, NCT05553691 in participants with MDD with or without SSRIs, and NCT05644093 comparing intramuscular and intravenous drug product in healthy participants. Total enrollment across these trials was 98 participants.
Yes, SPL026 IV is an alternative name for SPL026. It refers to the intravenous formulation of the drug, which was evaluated alongside an intramuscular formulation in the Phase 1 trial NCT05644093 conducted in healthy participants.