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To evaluate the safety of orally administered KSP-QRH-E3-IRDye800 (Peptide 919288G), a topically administered Li-Cor IRDye800CW labeled heptapeptide dimer (KSP/QRH Dimer) specific for human epithelial growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR).
This is a Phase IA study of the safety of an orally administered KSP-QRH-E3-IRDye800 (Peptide 919288G) heptapeptide dimer for detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans. The investigators intend to enroll 25 evaluable subjects. The investigators expect to be able to enroll about 2-3 subjects per week, so the study should take about 2-3 months to complete.
Interested, healthy subjects ages 25-100 who respond to recruitment advertising on UMHealthResearch.org and appear to be eligible based responses to inclusion/exclusion criteria questions 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, as well as have an EKG. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted KSP-QRH-E3-IRDye800 (Peptide 919288G). After 5 minutes, subjects will drink a minimum 4-8 ounces of tap water and vital signs will be taken. Subjects will remain in MCRU for observation for 30 minutes. Vital signs will be recorded after 30 minutes, and another EKG will be conducted. Subjects are required to return to MCRU to have a repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after KSP-QRH-E3-IRDye800 (Peptide 919288G) ingestion. The study team will conduct a verbal assessment for toxicity at this visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSP-QRH-E3-IRDye800 (Peptide 919288G) 0.6 mg subjects 1-3 | Experimental | The first three subjects will receive lyophilized powder reconstituted with 5 mL of 0.9% NaCl, 0.6 mg of KSP-QRH-E3-IRDye800 (Peptide 919288G) total. For the first three subjects, 3.34 mL of KSP-QRH-E3-IRDye800 (Peptide 919288G)will be discarded. The 1.66 mL of KSP-QRH-E3-IRDye800 (Peptide 919288G)remaining in the syringe will be administered by squirting it into the mouth of the subject. |
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| KSP-QRH-E3-IRDye800 (Peptide 919288G) 1.8 mg subjects 4-25 | Experimental | Following a safety review of the first three subjects receiving 0.6 mg dose, the remaining 22 subjects will receive the full 1.8 mg dose of KSP-QRH-E3-IRDye800 (Peptide 919288G) reconstituted in 5 mL 0.9% NaCl. These 22 subjects will receive all 5 mL of the peptide solution in a syringe for administration. The agent will not be reconstituted until the subject is ready to squirt the peptide into his or her mouth via syringe. They will be asked to wait 5 minutes and then drink at least 4-8 oz of tap water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg | Drug | The investigational agent to be used in this study is KSP/QRH dimer: a fluorescently-labeled peptide dimer composed of a 14-amino acid sequence [Lys-Ser-Pro-Asn-Pro-Arg-Phe] and [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a PEG3, Lys and Cys linker [PEG3]2-Lys-Cys to a near-infrared fluorophore, IRDye800CW (0.6 mg dose). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with abnormal lab values | review of laboratory values for abnormalities after intervention with KSP/QRH Dimer | 48 hours |
| Number of subjects with unexpected side effects | Side effects collected through their follow-up visit | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepa Chandhrasekhar, BS | University of Michigan | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D010455 | Peptides |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg | Drug | The investigational agent to be used in this study is KSP/QRH dimer: a fluorescently-labeled peptide dimer composed of a 14-amino acid sequence [Lys-Ser-Pro-Asn-Pro-Arg-Phe] and [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a PEG3, Lys and Cys linker [PEG3]2-Lys-Cys to a near-infrared fluorophore, IRDye800CW (1.8 mg dose). |
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