Study of the Safety of QRH-882260 Heptapeptide

NCT ID: NCT02574858

Last Updated: 2018-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-08-31

Brief 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).

Detailed 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).

Conditions

Healthy Adults

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

QRH-886620

The first three subjects will squirt via syringe into their mouths (po) 4.2 mg (2.1ml) mg of reconstituted (with 5 ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration). They will be asked to wait 5 minutes and then drink at least 4-8oz of tap water. The remaining seven subjects will receive (squirted via syringe into their mouths) 1mg (5ml) of reconstituted (with 5ml of 0.9% saline) QRH-882260 heptapeptide (\~100 µM concentration).

Group Type: EXPERIMENTAL

QRH-882260

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

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)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Danielle Kim Turgeon

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Michigan Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM00099903

Identifier Type: -

Identifier Source: org_study_id