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A Clinical Study of 68Ga-HX01 Injection for PET Imaging

Healthy Clinical Trial

Official title:
A Phase I Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dose and Pharmacokinetics of 68Ga-HX01 Injection for PET Imaging

Clinical Trial Summary

This is a single-center, open Phase I clinical study, consisting of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors.

Clinical Trial Description

Phase Ia design: The Phase Ia study is designed to evaluate the safety, biodistribution (PET imaging), radiation dose, and pharmacokinetics of 68Ga-HX01 injection after a single intravenous administration in healthy Chinese adult subjects. Twelve healthy adult subjects will be enrolled in the Phase Ia program. Phase Ib design: The purpose of the Phase Ib clinical study is to evaluate the safety and biodistribution (PET imaging) of patients with malignant solid tumors receiving a single intravenous administration of 68Ga-HX01 injection, and to explore the characteristics of tumor imaging. Ten patients with malignant solid tumors will be enrolled in Phase Ib. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06416774
Study type Interventional
Source Hexin (Suzhou) Pharmaceutical Technology Co., Ltd
Contact
Status Completed
Phase Phase 1
Start date December 29, 2022
Completion date October 30, 2023
View Details
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