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

PHASE1CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

December 29, 2022

Primary Completion Date

July 20, 2023

Study Completion Date

October 30, 2023

Conditions
HealthyMalignancy
Interventions
DRUG

68Ga-HX01 Injection(0.05mCi/kg)

"The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring.~They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments."

DRUG

68Ga-HX01 Injection(0.1mCi/kg)

"The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for radioactive counts for pharmacokinetic analysis and safety monitoring.~They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments."

DRUG

68Ga-HX01 Injection(0.07mCi/kg)

"The study is divided into three stages, including screening period, administration period and follow-up observation period. The maximum screening period is 7 days. Eligible subjects will receive intravenous injection of the experimental drug 68Ga-HX01 on Day 1 of the study and undergo PET imaging, while blood and urine are collected for safety monitoring.~They will return to the study center for safety checks on Day 2 after injection and phone follow-up on Day 7 for adverse events and drug combinations/treatments."

Trial Locations (1)

430022

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

lead

Hexin (Suzhou) Pharmaceutical Technology Co., Ltd

INDUSTRY

NCT06416774 - A Clinical Study of 68Ga-HX01 Injection for PET Imaging | Biotech Hunter | Biotech Hunter