Technetium [99mTc]-H7ND in Patients With Gastrointestinal Malignancies and Healthy Volunteers
NCT06443710 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2025-07-15
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
Interventions
- DRUG
-
Technetium [99mTc]-H7ND injection
Technetium \[99mTc\]-H7ND injection is a radiolabeled fibroblast activation protein inhibitor
Sponsors & Collaborators
-
Jiaxing Pharmadax Genesis Pharmaceutical Technology Co.,Ltd.
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-14
- Primary Completion
- 2024-11-19
- Completion
- 2024-11-19
Countries
- China
Study Locations
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