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Technetium [99mTc]-H7ND in Patients With Gastrointestinal Malignancies and Healthy Volunteers

Solid Tumor Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06443710
Study type Interventional
Source Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.
Contact
Status Not yet recruiting
Phase Phase 1
Start date May 30, 2024
Completion date December 31, 2024
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