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
A Phase 1, single-center, open-label, single arm, baseline-controlled (for safety) study in normal volunteers. Study will determine biodistribution and excretion of the radioactive drug substance and evaluate the safety and tolerability of 99mTC-Etarfolatide in normal volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm - Healthy Volunteers | Experimental | Etarfolatide (EC20) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etarfolatide (EC20) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distribution of Radioactive Drug Substance | To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of 99mTc-Etarfolatide in Normal Volunteers | Asses any adverse events and serious adverse events experienced by volunteers. | 4 days post-injection of EC20 |
| Tolerability of 99mTc-Etarfolatide in Normal Volunteers |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of SPECT images of Normal Volunteers with or without injection of Folic Acid | Comparison made of SPECT images taken of volunteers who received folic acid injection prior to 99mTc-EC20 injection and those who did not receive folic acid injection. Readability of scans, background "noise" as well as evaluation of any other differences will be noted. | 24 hours |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wael Harb, MD | Horizon Oncology Research, Inc. | Principal Investigator |
| Beth Safirstein, MD | MD Clinical | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Clinical | Hallendale | Florida | United States | |||
| Horizon Oncology |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Asses any adverse events and serious adverse events experienced by volunteers.
| 4 days |
| Lafayette |
| Indiana |
| United States |