Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
Study NCT ID:
NCT07107802
Status:
COMPLETED
Last Update Posted:
2025-11-28
First Post:
2025-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Single Ascending Dose Study With ATX101
Sponsor:
Aurobac Therapeutics SAS
Organization:
Study Overview
Official Title:
A Phase 1, Single Ascending Dose Study, to Assess the Safety and Pharmacokinetics of Intravenous ATX101 in Healthy Participants
Status:
COMPLETED
Status Verified Date:
2025-11
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:
The main objective of this study is to assess the safety and tolerability of intravenously administered ATX101 in healthy adults following single ascending doses of ATX101. The pharmacokinetic profile of ATX101 and its metabolites will also be investigated.
Detailed Description:
This is a single-center, double-blinded, placebo-controlled, phase I, single ascending dose study in healthy participants. A maximum of three ATX101 dose levels are pre-planned to be investigated in three separate sequential cohorts. Each of these cohorts will consist of 8 healthy participants (6 participants randomized to ATX101 and 2 to placebo). The study will consist of:
* a screening period, within 7 to 21 days before investigational product administration (Day -21 to Day -7),
* a treatment period, including admission to confinement, 3-night confinement, and discharge from confinement.
* a follow-up period, which includes two ambulatory follow-up visits (Day 4 and Day 7).
Total duration of study participation for each participant will be approximately 4 weeks.
* a screening period, within 7 to 21 days before investigational product administration (Day -21 to Day -7),
* a treatment period, including admission to confinement, 3-night confinement, and discharge from confinement.
* a follow-up period, which includes two ambulatory follow-up visits (Day 4 and Day 7).
Total duration of study participation for each participant will be approximately 4 weeks.
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 |
|---|---|---|---|---|
| 2025-521999-56-00 | CTIS | None | View |