Clinical trial NCT03643068: Phase 1A Study of the Safety of KSP/QRH Dimer
Official title: Phase 1A Study of the Safety of KSP/QRH Dimer in Humans for the Early Detection of GI Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adults
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of subjects with abnormal lab values
timeFrame: 48 hours
measure: Number of subjects with unexpected side effects
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Deepa Chandhrasekhar, BS
role: STUDY_CHAIR
References: