Skip to main content
OpenTrials
Completed

NCT Number: NCT02574858

Study of the Safety of QRH-882260 Heptapeptide

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Adults

Age range

25 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

QRH-882260

Drug

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

Primary outcomes

  1. Number of Subjects With Abnormal Lab Values

    Time frame: 48 hours

    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.

  2. Number of Subjects With Abnormal EKG

    Time frame: 30 minutes

    Review of EKG for abnormalities after intervention with QRH-882260. Paired EKGs will be reviewed for electrical changes post QRH-882260 ingestion.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Acronym: QRH-882260

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 14, 2015
Registry last updated
Jan 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.