NCT03161418

Study of the Safety of KSP Heptapeptide (KSP-910638G)

Study of the Safety of KSP Heptapeptide (KSP-910638G) 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

The purpose of this study is to evaluate the safety of orally administered KSP-910638G, a topically administered li-cor IRDye800CW labeled heptapeptide specific for human epithelial growth factor receptor 2 (HER2).

Detailed description

This is a Phase IA study of the safety of an orally administered KSP-910638G heptapeptide 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 1-2 subjects per week, so the study should take about 4-6 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. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted KSP-910638G. 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. 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-910638G ingestion. The study team will conduct a verbal assessment for toxicity at this visit.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	KSP-910638G, 0.4 mg	The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (0.4 mg dose)
DRUG	KSP-910638G, 1.2 mg	The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (1.2 mg dose)

Timeline

• Start date: 2017-06-21
• Primary completion: 2017-09-20
• Completion: 2017-09-20
• First posted: 2017-05-19
• Last updated: 2017-12-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study