Healthy Adults Clinical Trial
The purpose of this study is to evaluate the safety of orally administered QRH-882260, a topically administered Cy5-labeled heptapeptide specific for epithelial growth factor receptor (EGFR).
This is a Phase IA study of the safety of an orally administered QRH-882260 heptapeptide for
detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans.
The investigators intend to enroll 10 evaluable subjects. The investigators expect to be able
to enroll about 1-2 subjects per week, so the study should take about 1-2 months to complete.
Interested, healthy subjects ages 25-100 who respond to recruitment advertising and appear to
be eligible based on a screening questionnaire will be scheduled for a study visit at MCRU.
At the study visit, the subjects will review and sign the informed consent and eligibility
will be confirmed. If eligible, subjects will provide a blood sample for clinical labs and a
urine sample for urinalysis. A baseline EKG will be recorded. A negative urine pregnancy test
for women of child-bearing potential is required to be eligible. Eligible subjects will
consume the reconstituted QRH-882260 heptapeptide. After 5 minutes, subjects will drink a
minimum 4-8 ounces of tap water. Subjects will remain in MCRU for observation for 30 minutes.
Vital signs and an EKG will be recorded after 30 minutes. Subjects are required to have
repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after QRH-882260
heptapeptide ingestion. The study team will conduct a follow up phone call to verbally assess
toxicity after post-ingestion labs (within 7 days).
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