NCT06443710

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

A Phase I Clinical Study of the Pharmacokinetics and Safety of Technetium [99mTc]-H7ND Injection in Patients With Gastrointestinal Malignancies and Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Technetium [99mTc]-H7ND injection	Technetium \[99mTc\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor

Timeline

• Start date: 2024-05-14
• Primary completion: 2024-11-19
• Completion: 2024-11-19
• First posted: 2024-06-05
• Last updated: 2025-07-15

Locations

1 site across 1 country: China