Evaluation of the Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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A Single-Center Phase I Clinical Study to Evaluate The Biodistribution and Safety of 99mTC-Etarfolatide (EC20) in Normal Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Etarfolatide (EC20)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must be 18 years of age or older. Subject must not have any major health problems as deemed by principal investigator. Subject must provide informed consent prior to enrollment. Exclusion Criteria: Subject is pregnant or breast-feeding. Subject is simultaneously participating in another investigative drug or device study. Subject must have completed the follow-up phase of any previous study at least 30 days prior to enrollment in this study. Subject has a known history of chronic abuse of drugs or alcohol or tests positive in pre-study urine drug abuse screen. Subject is currently taking folic acid supplements and cannot stop taking the supplements for a period of 8 days (7 days prior to the study and one day after last imaging procedure). Subject's physical condition unsuitable for radionuclide imaging. Subject has been administered another radiopharmaceutical that would interfere with the assessment of the biodistribution of 99mTc-etarfolatide.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm - Healthy Volunteers<br>Etarfolatide (EC20) | Drug: Etarfolatide (EC20)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Asses any adverse events and serious adverse events experienced by volunteers. | 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Volunteers