Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400771
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-04-29
Brief Title:
Safety of DNP007 in Healthy Subjects
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Exploratory Single-dose Phase I Clinical Trial to Evaluate the Safety Tolerability and Pharmacokinetics of DNP007 in Healthy Subjects
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:
None
Brief Summary:
This clinical trial evaluated the safety tolerability pharmacokinetic properties and immunogenicity of DNP007 when administered as a single dose Since this is a phase 1 study for exploratory evaluation to the extent that it meets the study objectives In order to proceed with the minimum number of subjects a total of 12 people 3 for each dose group was planned as the target number
Detailed Description:
For volunteers only screening tests such as questionnaires physical examinations and clinical laboratory tests will be conducted within 4 weeks -28d to -1d from the date of clinical trial conduct to select test subjects deemed suitable for this clinical trial Subjects determined to be suitable for this clinical trial are admitted to the Seoul National University Hospital Clinical Trial Center in the afternoon one day -1d before the first administration of the investigational drug and must fast for at least 10 hours In the morning of Day 1 test subjects receive intravenous administration of the clinical trial drug for 30 minutes Pharmacokinetics immunogenicity and safety evaluations are conducted according to the planned schedule Test subjects are hospitalized at the clinical trial center for 4 days discharged on the 4th day and after administration of the investigational drug on 8d 11d 15d 22d 1d and 29d 2d for pharmacokinetics immunogenicity and safety evaluation Visit the clinical trial center It proceeds sequentially starting from the lowest dose group and whether to proceed to the next dose is decided based on the tolerability and safety results up to 15 days of the previous dose
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