drugset / Trial / NCT05839509
Phase 2 Clinical Trial of GH001 in Bipolar II Disorder
NaSingle-groupOpen-labelTreatment
Summary
This study is a multicenter, open-label, single-arm Phase 2 clinical trial. Approximately 15 participants with clinically diagnosed bipolar disorder (BD) type II and experiencing a current episode of depression will be included in this study. The participants will receive an individualized dosing regimen (IDR) with at least one and up to three doses of GH001 administered within a single day.
Timeline
- Start
- 2023-04-06
- Primary completion
- 2024-11-13
- Completion
- 2024-12-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mebufotenin | Small molecule | 6 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 12 mg | Inhaled |
| Subject | Mebufotenin | Small molecule | 18 mg | Inhaled |