Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT05644093
Status:
COMPLETED
Last Update Posted:
2024-03-22
First Post:
2022-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IM and IV SPL026 Drug Product in Healthy Participants
Sponsor:
Small Pharma Ltd
Organization:
Study Overview
Official Title:
Open-label, Cross-over Study of IM and IV Doses of SPL026 in Healthy, Psychedelic-experienced Participants (Part A: IM and IV Doses) and Participants With Little to no Psychedelic Experience (Part B: IM Dose Only)
Status:
COMPLETED
Status Verified Date:
2024-03
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 goal of this clinical trial is to test SPL026 given via injection into a muscle in healthy volunteers.
Detailed Description:
Part A: Crossover IM then IV dosing with SPL026 in psychedelic experienced, healthy volunteers.
PART B: IM dosing only with SPL026 in less experienced/psychedelic naive, healthy volunteers.
PART B: IM dosing only with SPL026 in less experienced/psychedelic naive, healthy volunteers.
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?: