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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
23
MD Clinical
Hallendale, Florida, United States
Horizon Oncology
Lafayette, Indiana, United States
Distribution of Radioactive Drug Substance
To measure distribution of radioactivity from 99mTc-EC20 injection in blood and urine samples.
Time frame: 24 hours
Safety of 99mTc-Etarfolatide in Normal Volunteers
Asses any adverse events and serious adverse events experienced by volunteers.
Time frame: 4 days post-injection of EC20
Tolerability of 99mTc-Etarfolatide in Normal Volunteers
Asses any adverse events and serious adverse events experienced by volunteers.
Time frame: 4 days
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