SPL026 (DMT Fumarate) in Healthy Subjects and MDD Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Major Depressive Disorder
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: RCTPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
2-part study. Part A in psychedelic-naïve healthy volunteers. Part B in patients with MDD who score moderate-severe on Ham-D. Healthy volunteers will receive a single dose of SPL026 in a dose-escalation parallel group study. Patients will receive up to 2 single doses of SPL026, 2 weeks apart. Dose 1...
2-part study. Part A in psychedelic-naïve healthy volunteers. Part B in patients with MDD who score moderate-severe on Ham-D. Healthy volunteers will receive a single dose of SPL026 in a dose-escalation parallel group study. Patients will receive up to 2 single doses of SPL026, 2 weeks apart. Dose 1 will be randomised double-blind with placebo. Dose 2 will be open label, active SPL026. SPL026 will be administered by IV injection. Safety and tolerability, PK, PD and efficacy will be measured.
Tracking Information
- NCT #
- NCT04673383
- Collaborators
- Not Provided
- Investigators
- Study Director: Jan Steiner, MD Oxford Therapeutics Consulting Principal Investigator: David Erritzoe, MD Imperial College London Principal Investigator: Malcolm Boyce, MD Hammersmith Medicines Research
Get Well Soon