Ignite Creation Date:
2024-07-17 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480968
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2023-07-27
Brief Title:
CTH120 First-in-Human Study Single and Multiple Ascending Doses and Potential Food Interaction
Sponsor:
Connecta Therapeutics SL
Organization:
Connecta Therapeutics SL
Study Overview
Official Title:
Safety and Tolerability of CTH120 First-in-human Phase I Study Encompassing Three Parts Single and Multiple Ascending Doses and Potential Food Interaction
Status:
RECRUITING
Status Verified Date:
2024-06
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:
FIH-CTH120
Brief Summary:
The purpose of this First-in-Human Phase I study is to investigate the safety tolerability and pharmacokinetics of CTH120 in adult healthy volunteers
Detailed Description:
This trial is divided in three parts FIH-CTH120-SAD Single Ascending Doses FIH-CTH120-MAD Multiple Ascending Doses and FIH-CTH120-FI Food Interaction FIH-CTH120-SAD will start first The start of FIH-CTH120-MAD will await the results of at least three cohorts from the FIH-CTH120-SAD study before initiated The starting dose of the FIH-CTH120-MAD will have been shown to be well tolerated in FIH-CTH120-SAD FIH-CTH120-FI will be the last to start
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502209-13-01 | OTHER | None | None |