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

NCT06416774 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-05-16

No results posted yet for this study

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.

Conditions

  • Healthy
  • Malignancy

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.

Sponsors & Collaborators

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

    collaborator OTHER

  • Hexin (Suzhou) Pharmaceutical Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-29
Primary Completion
2023-07-20
Completion
2023-10-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06416774 on ClinicalTrials.gov