Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511947
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-28
Brief Title:
Pharmacokinetics of GH001 Delivered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-label Phase 1 Trial to Determine the Pharmacokinetics Pharmacodynamics and Safety of GH001 Administered Via a Proprietary Aerosol Delivery Device in Healthy Subjects
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 TCmax2 and TCmax10 time taken for Cmax to decrease by 50 and 90 respectively are also assessed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None