Clinical trial NCT06416774: A Clinical Study of 68Ga-HX01 Injection for PET Imaging
Official title: A Phase I Clinical Study to Evaluate the Safety, Biodistribution, Radiation Dose and Pharmacokinetics of 68Ga-HX01 Injection for PET Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Malignancy
Lead sponsor: Hexin (Suzhou) Pharmaceutical Technology Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Wuhan Union Hospital, China
First posted: 2024-05-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: This study consists of two parts: a Phase Ia study in healthy adult subjects and a Phase Ib study in patients with malignant solid tumors.

Phase Ia:

Inclusion Criteria:

* 18-50 years old;
* Female weight 45-80kg, male weight 50-80kg;
* Agree to take effective contraception during the study and for at least three months after the drug administration.

Exclusion Criteria:

* Pregnant or lactating women; Or plan to donate sperm or eggs during the study or within three months after drug administration;
* Known or suspected allergic to the test drug or any of its components;
* Receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment;
* Those who tested positive for hepatitis B/C virus, syphilis or HIV during screening;
* Clinically significant abnormalities in hematology, blood biochemistry, and urine routine during screening;
* Patients with clinically significant diseases within 4 weeks before screening;
* Blood pressure higher than 150/100 mmHg or lower than 90/50 mmHg at screening;
* Use of any prescription or over-the-counter drugs within 2 weeks before the trial drug administration;
* Blood donation or blood loss ≥500 mL within 12 weeks before administration;
* History of drug or alcohol abuse within 12 months prior to administration;
* Smoking more than 5 cigarettes a day or consuming the same amount of nicotine or nicotine replacement within 3 months before administration;
* History of malignancy;
* Plan to schedule surgery and other invasive interventions within one week of the test drug injection;
* Compliance to lie for about 90 minutes during the PET examination.

Phase Ib:

Inclusion Criteria:

* Patients with malignant solid tumors with measurable lesions (target lesions) confirmed by histopathology or cytology or clinical diagnosis;
* 18-75 years old;
* Eastern Cooperative Oncology Group (ECOG) score 0 or 1;
* life expectancy ≥6 months;
* Agree to take effective contraception during the study and for at least three months after the drug administration.

Exclusion Criteria:

* Pregnant or lactating women; Or plan to donate sperm or eggs during the study or within three months after drug administration;
* Known or suspected allergic to the test drug or any of its components;
* Receiving another investigational drug at the time of enrollment, or within 5 half-lives of the drug at the time of enrollment;
* Those who tested positive for hepatitis B/C virus, syphilis or HIV during screening;
* Any radiotherapeutic drugs used within 90 days before administration, or any radionuclide diagnostic drugs received within 3 days before administration;
* Plan to schedule surgery and other invasive interventions within 2 days after trial drug injection;
* Abnormal liver and kidney function: serum total bilirubin (TBIL) \> 1.5×ULN (upper limit of normal), or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 2.5×ULN, or serum creatinine \> 1.5×ULN;
* With active infection at the time of screening;
* Compliance to lie for about 60 minutes during the PET examination.

Primary outcomes:
measure: Temperature
timeFrame: During the screening period (within 7 days), within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
measure: Respiration
timeFrame: Time Frame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
measure: Pulse
timeFrame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
measure: Blood pressure
timeFrame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
measure: Oxygen saturation
timeFrame: During the screening period, within 30 minutes before 68Ga-HX01 administration, 1.0 to 1.5 hours, 3.0 to 3.5 hours after the injection and Day 2.
measure: Electrocardiogram QT Interval
timeFrame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
measure: Electrocardiogram QRS Interval
timeFrame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
measure: Electrocardiogram PR Interval
timeFrame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
measure: Electrocardiogram T Wave
timeFrame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
measure: Electrocardiogram ST Segment
timeFrame: Within 30 minutes before 68Ga-HX01 administration, 3.0 to 3.5 hours after the injection and Day 2.
measure: Number of Participants With Abnormal Laboratory Values in Blood routine
timeFrame: Day 2.
measure: Number of Participants With Abnormal Laboratory Values in Blood biochemistry
timeFrame: Day 2.
measure: Prothrombin time test and/or a partial thromboplastin time test (PTT)
timeFrame: Day 2.
measure: Number of Participants With Abnormal Laboratory Values in Urine routine
timeFrame: Day 2.
Secondary outcomes:
measure: Dosimetry
timeFrame: At 10, 30, 60 and 120 minutes after 68Ga-HX01 injection.
measure: The percentage of injected dose per gram (% ID/g)
timeFrame: Blood samples are collected for the radioactivity determination before (within 30 minutes) and after 68Ga-HX01 injection at different time points (2, 5, 10, 30, 60, 90, 120, and 180 minutes).
measure: The max uptake of each lesion
timeFrame: At 30 and 60 minutes after 68Ga-HX01 injection.
measure: The mean uptake of each lesion
timeFrame: At 30 and 60 minutes after 68Ga-HX01 injection.
measure: Lesion number
timeFrame: At 30 and 60 minutes after 68Ga-HX01 injection.
measure: The size of each lesion
timeFrame: At 30 and 60 minutes after 68Ga-HX01 injection.
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
References: