Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 12:00 AM
Study NCT ID:
NCT05753956
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2023-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Pharmacokinetics of GH002 in Healthy Volunteers
Sponsor:
GH Research Ireland Limited
Organization:
Study Overview
Official Title:
A Phase 1 Clinical Trial to Determine the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous GH002 in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study are to investigate the safety and serum pharmacokinetics of 5-MeO-DMT in healthy volunteers in a double-blind, placebo-controlled, randomized study design with single, injected doses of GH002 and in an open-label, non-randomized study design with intra-subject dose-escalation of GH002. As secondary objectives, the PK/ pharmacodynamic relationship, PD profile of GH002 as evaluated by its psychoactive effects and impact on cognitive performance, and the serum PK of the metabolite bufotenine are also assessed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-002620-13 | EUDRACT_NUMBER | None | View |