NCT03643068

Phase 1A Study of the Safety of KSP/QRH Dimer

Phase 1A Study of the Safety of KSP/QRH Dimer in Humans for the Early Detection of GI Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 25 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	KSP-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).
DRUG	KSP-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).

Timeline

• Start date: 2018-08-22
• Primary completion: 2018-10-27
• Completion: 2018-10-27
• First posted: 2018-08-22
• Last updated: 2018-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study