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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ga68-Dolacga Injection | Experimental | The healthy volunteer was injected with Ga68-Dolacga Injection iv and performed PET imaging for liver reserve evaluation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga68-Dolacga Injection | Drug | Ga68-Dolacga Injection, 3.5±0.25 mCi, single dose iv |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects reporting clinically significant changes in serum biochemical tests | from pre-dose to 14±2 days post dose | |
| Number of subjects reporting clinically significant changes in hematological tests | from pre-dose to 14±2 days post dose | |
| Number of subjects reporting clinically significant changes in urinalysis | from pre-dose to 14±2 days post dose | |
| Number of subjects with clinically significant changes in systolic blood pressure and diastolic blood pressure | from pre-dose to 14±2 days post dose | |
| Number of subjects with body temperature abnormalities | 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 | visit 2 (Day 1) |
| Number of subjects with clinically significant changes in Heart Rate | 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) | from pre-dose to 14±2 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 60 minutes after administration of Ga68-Dolacga Injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yao-Ming Wu, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 10617 | Taiwan |
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| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. | 14 days |