This is a phase 1 study to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy volunteers.
Ga-68 is a positron-emitting radionuclide with short half-life of 68 minutes. Dolacga is a non-radiolabeled formulated drug product and will be reconstituted to become the finished radiopharmaceutical product Ga68-Dolacga Injection, a PET tracer specifically targeting to surface receptors of hepatocytes. The study aims to evaluate the safety of Ga68-Dolacga Injection in healthy volunteers and to assess the normal reference range and inter-individual variability of the Ga68-Dolacga Injection in estimating liver reserve in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
Ga68-Dolacga Injection, 3.5±0.25 mCi, single dose iv
National Taiwan University Hospital
Taipei, Taiwan
Number of subjects reporting clinically significant changes in serum biochemical tests
Time frame: from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in hematological tests
Time frame: from pre-dose to 14±2 days post dose
Number of subjects reporting clinically significant changes in urinalysis
Time frame: from pre-dose to 14±2 days post dose
Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure
Time frame: from pre-dose to 14±2 days post dose
Number of subjects with body temperature abnormalities
Time frame: from pre-dose to 14±2 days post dose
Abnormalities of physical examination in visit 2 (post-treatment) compared with visit 1
Including the examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular and neurological
Time frame: visit 2 (Day 1)
Number of subjects with clinically significant changes in Heart Rate
Time frame: from pre-dose to 14±2 days post dose
Number of subjects with clinically significant changes in electrocardiogram(ECG)
The ECG parameters include: PR interval (milliseconds), QTc interval (milliseconds), QRS duration (milliseconds)
Time frame: from pre-dose to 14±2 days post dose
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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All laboratory abnormalities which are compared with screening values and out of the reference range will be considered as AE and will be assessed its relationship to the study drug. Any ECG changes including ECG waveform will be assessed as AE(s) and will be followed to assess whether they resolved and when they resolved.
Time frame: 14 days
Establishment of the normal reference range of the percent of injection dose (%ID) in healthy liver
The normal reference range will be measured by the mean +/- standard deviation of the liver %ID of all of the phase 1 volunteers.
Time frame: up to 60 minutes after administration of Ga68-Dolacga Injection