Healthy Adults
Conditions
Brief summary
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).
Detailed description
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.
Interventions
DRUGKSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg
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).
DRUGKSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg
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).
Sponsors
University of Michigan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Not pregnant (willing to have pregnancy test if applicable) * No recent illness (infection, URI, virus or flu) within 2 weeks, * Stable health status (i.e. no medication changes within 2 months, no recent surgery, etc. per PI) * Willing and able to sign informed consent * Willing and able to drink the peptide and a tap water chaser * Willing and able to get baseline and 24-48 hours post ingestion labs * Willing and able to get pre and post ingestion EKG
Exclusion criteria
* Known allergy to li-cor IRDye800CW, a near infrared fluorosphore or derivatives * Subjects on active chemotherapy or radiation therapy * Diabetics on insulin/hypoglycemic (due to fasting requirements)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with abnormal lab values | 48 hours | review of laboratory values for abnormalities after intervention with KSP/QRH Dimer |
| Number of subjects with unexpected side effects | 48 hours | Side effects collected through their follow-up visit |
Countries
United States
Outcome results
None listed