Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443710
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-23
Brief Title:
Technetium 99mTc-H7ND in Patients With Gastrointestinal Malignancies and Healthy Volunteers
Sponsor:
Jiaxing Pharmadax Genesis Pharmaceutical Technology CoLtd
Organization:
Jiaxing Pharmadax Genesis Pharmaceutical Technology CoLtd
Study Overview
Official Title:
A Phase I Clinical Study of the Pharmacokinetics and Safety of Technetium 99mTc-H7ND Injection in Patients With Gastrointestinal Malignancies and Healthy Volunteers
Status:
RECRUITING
Status Verified Date:
2024-09
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 primary objective of this study is to evaluate the safety of technetium 99mTc-H7ND injection in patients with gastrointestinal malignancies and in healthy subjects The secondary objectives of this study are 1 to examine the pharmacokinetics of technetium 99mTc-H7ND Injection in healthy subjects 2 Detect the metabolic stability of technetium 99mTc-H7ND injection in healthy humans 3 Detect the biodistribution and estimate the absorbed dose of radiation from internal irradiation of technetium 99mTc-H7ND injection in patients with malignant tumors of the gastrointestinal tract and in healthy humans
Detailed Description:
None
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