Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360640
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-05
Brief Title:
A First-in-human Trial to Evaluate Safety Tolerability and Pharmacokinetics of APC148 in Healthy Adults
Sponsor:
AdjuTec Pharma AS
Organization:
AdjuTec Pharma AS
Study Overview
Official Title:
A First-in-human Randomised Double-blind Placebo-controlled Single Ascending Dose Trial to Evaluate Safety Tolerability and Pharmacokinetics of APC148 in Healthy Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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 purpose of this first-in-human trial is to investigate the safety tolerability and pharmacokinetics of APC148 after intravenous IV infusion of single ascending doses in healthy adults
Detailed Description:
Participants will receive a single 3-hours IV infusion of APC148 or placebo 6 sequential cohorts are planned The first 2 subjects in each cohort will be dosed in a sentinel fashion The subjects will be followed for 7 days
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507939-38-00 | OTHER | EU Trial no | None |