Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 2:57 PM
Study NCT ID:
NCT07035769
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of Debio 1453P in Healthy Adults
Sponsor:
Debiopharm International SA
Organization:
Study Overview
Official Title:
A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Oral Doses of Debio 1453P in Healthy Adults
Status:
RECRUITING
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 purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of Debio 1453P compared to placebo across different dose levels in healthy adults after single and repeated oral dosing.
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?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1315-2035 | OTHER | WHO Universal Trial Number | View | |
| 75A50122C00028 | OTHER_GRANT | HHS/BARDA OTA Number | View | |
| 224842/Z/21/Z | OTHER_GRANT | Wellcome Trust | View | |
| NNF23SA0088536 | OTHER | Novo Nordisk Foundation (NNF) | View | |
| Agreement Dated 1/30/2023 | OTHER | Germany's Federal Ministry of Research, Technology and Space (BMFTR) | View | |
| Agreement Dated 2/28/2023 | OTHER | Global Antimicrobial Resistance Innovation Fund (GAMRIF) | View | |
| 2024-519328-26 | OTHER | EU CT Number | View |