Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT05555758
Status:
COMPLETED
Last Update Posted:
2024-11-27
First Post:
2022-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aom0319 SAD Study in Healthy Subjects
Sponsor:
Amckaus PTY LTD.
Organization:
Study Overview
Official Title:
A Single-Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics Profile of Aom0319 in Healthy White Subjects
Status:
COMPLETED
Status Verified Date:
2024-11
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:
Only SAD study will be conducted in this project. SAD represents single ascending dose. Multiple ascending dose have been cancelled. This decision has been made at the discretion of the Sponsor.
Detailed Description:
This study was designed to evaluate the safety and tolerability of Aom0319.
The trial is designed as follows.
1\. SAD: 32 participants will be studied in four groups with n = 8 (6 active: 2 placebo) per group.
The trial is designed as follows.
1\. SAD: 32 participants will be studied in four groups with n = 8 (6 active: 2 placebo) per group.
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?: