drugset / Trial / NCT06511947
Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The primary objectives of this trial are to determine the pharmacokinetic (PK) profile and the safety and tolerability of GH001 delivered via a proprietary aerosol delivery device in healthy subjects after single-dose administration and a single-day individualized dosing regimen (IDR). As secondary objectives, the mebufotenin PK/ pharmacodynamic (PD) relationship, the PD profile of GH001 as evaluated by its psychoactive effects (PsE), the impact on cognitive performance, and the TCmax/2 and TCmax/10 (time taken for Cmax to decrease by 50 and 90%, respectively) are also assessed.
Timeline
- Start
- 2024-08-01
- Primary completion
- 2025-02
- Completion
- 2025-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mebufotenin | Small molecule | 6 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 8 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 9 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 10 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 12 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 14 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 15 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 16 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 18 mg | Inhaled |
Indications
No indication recorded.