Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416774
Status:
COMPLETED
Last Update Posted:
2024-05-16
First Post:
2024-05-11
Brief Title:
A Clinical Study of 68Ga-HX01 Injection for PET Imaging
Sponsor:
Hexin Suzhou Pharmaceutical Technology Co Ltd
Organization:
Hexin Suzhou Pharmaceutical Technology Co Ltd
Study Overview
Official Title:
A Phase I Clinical Study to Evaluate the Safety Biodistribution Radiation Dose and Pharmacokinetics of 68Ga-HX01 Injection for PET Imaging
Status:
COMPLETED
Status Verified Date:
2024-05
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:
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
Detailed 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
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 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