Study of the Safety of QRH-882260 Heptapeptide

Healthy Adults Clinical Trial

— QRH-882260  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02574858
• Other study ID #: HUM00099903
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2015
• Last updated: December 5, 2017
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: December 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety of orally administered QRH-882260, a topically administered Cy5-labeled heptapeptide specific for epithelial growth factor receptor (EGFR).

Description:

This is a Phase IA study of the safety of an orally administered QRH-882260 heptapeptide for detection of neoplastic tissues in multiple areas of the gastrointestinal tract in humans. The investigators intend to enroll 10 evaluable subjects. The investigators expect to be able to enroll about 1-2 subjects per week, so the study should take about 1-2 months to complete.

Interested, healthy subjects ages 25-100 who respond to recruitment advertising and appear to be eligible based on a screening questionnaire 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 baseline EKG will be recorded. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted QRH-882260 heptapeptide. After 5 minutes, subjects will drink a minimum 4-8 ounces of tap water. Subjects will remain in MCRU for observation for 30 minutes. Vital signs and an EKG will be recorded after 30 minutes. Subjects are required to have repeat blood draw for clinical labs and urinalysis within 24 to 48 hours after QRH-882260 heptapeptide ingestion. The study team will conduct a follow up phone call to verbally assess toxicity after post-ingestion labs (within 7 days).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 100 Years

Eligibility

Inclusion Criteria

• Adults age 25 to 100 years

• 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 Exclusion Criteria

• Known allergy to Cy5 or derivatives, such as indocyanine green (ICG)

• Subjects on active chemotherapy or radiation therapy

• Diabetics on insulin/hypoglycemic (due to fasting requirements)

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• QRH-882260
The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects With Abnormal Lab Values	Review of laboratory values for abnormalities after intervention with QRH-882260. If the first post-procedure labs are outside normal range, they must be within 20% of the subject's baseline lab values or returning towards normal range. Lab values not meeting these criteria must be repeated weekly until they peak and weekly until normal or within 20% of baseline level or within normal range.	48 hours
Primary	Number of Subjects With Abnormal EKG	Review of EKG for abnormalities after intervention with QRH-882260. Paired EKGs will be reviewed for electrical changes post QRH-882260 ingestion.	30 minutes