Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2026-01-04 @ 4:35 PM
Study NCT ID:
NCT05569720
Status:
COMPLETED
Last Update Posted:
2022-10-06
First Post:
2022-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First in Human Study to Compare Safety Between Intravenous Bolus Versus Infusion of ApTOLL
Sponsor:
aptaTargets S.L.
Organization:
Study Overview
Official Title:
First in Human Clinical Trial to Compare Safety and Tolerability Between Intravenous Infusions and Bolus Intravenous Inhection of ApTOLL in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2022-10
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:
APTABOLUS
Brief Summary:
The main objective of the study is to assess the tolerability and safety of ApTOLL administration when comparing intravenous infusion vs. bolus intravenous injection, in healthy volunteers. Pharmacokinetic profile of ApTOLL will be also analysed as secondary objective of the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: