Algernon Pharmaceuticals
This study aims to assess the safety and tolerability of single ascending, and fixed repeated doses of N,N-Dimethyltryptamine (DMT) in healthy subjects, when given by intravenous (IV) infusion.
Stroke
N,N-Dimethyltryptamine
Placebo
Phase 1
Study Type : | Interventional |
Estimated Enrollment : | 60 participants |
Masking : | Double |
Primary Purpose : | Treatment |
Official Title : | A Double-blind, Randomised, Placebo-controlled Study to Evaluate the Pharmacokinetics, Safety and Pharmacodynamics of Ascending Single and Fixed Repeat Intravenous Doses of DMT in Healthy Subjects |
Actual Study Start Date : | January 13, 2023 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | March 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: Part A: Single Dose Active Subjects will receive a single IV dose of DMT, administered as a bolus loading dose followed by a 6-h infusion. The starting dose will be 1.5 mg bolus, followed by a 0.105 mg/min infusion. Subsequent doses will be based on the safety and tolerability data from previous groups. |
Drug: N,N-Dimethyltryptamine |
Placebo Comparator: Part A: Single Dose Placebo Subjects will receive a single IV dose of placebo, administered as a bolus loading dose followed by a 6-h infusion. |
Drug: Placebo |
Experimental: Part B: Multiple Dose Active Subjects will receive a total of 6 doses of DMT, given as a bolus loading dose, followed by a IV infusion over 6 h, on Days 1, 3, 5, 8, 10, and 12 of a 2-week treatment period. Dose to be determined from single dose phase. |
Drug: N,N-Dimethyltryptamine |
Placebo Comparator: Part B: Multiple Dose Placebo Subjects will receive a total of 6 doses of placebo, given as a bolus loading dose, followed by IV infusion over 6 h, on Days 1, 3, 5, 8, 10, and 12 of a 2-week treatment period. |
Drug: Placebo |
Ages Eligible for Study: | 18 Years to 60 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Centre for Human Drug Research
Leiden, Netherlands,