Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of the study is to assess the dose dependent changes in MRI signal intensity (SI) in liver after IOP Injection intravenous administration in healthy volunteers.
Find the max. signal change after IOP administration
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOP Injection, Phase 1b, Cohort 1 | Experimental | IV injection, 0.27 mg/kg |
|
| IOP Injection, Phase 1b, Cohort 2 | Experimental | IV injection, 0.54 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOP Injection | Drug | T1 and T2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change of MRI SI (%) in vessels, liver, and spleen | The optimal imaging time of IOP injection for the maximum SI (%) | Day1: within 60 mins after IOP administration |
| Measure | Description | Time Frame |
|---|---|---|
| The changes from baseline in hematology data | Complete blood count and differential count, Reticulocyte count | within 14 days |
| The incidence of all treatment-related adverse events (TRAE) | within 14 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rheun-Chuan Lee, MD | rclee@vghtpe.gov.tw | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei County | 112 | Taiwan |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided