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Completed

NCT Number: NCT03643068

Phase 1A Study of the Safety of KSP/QRH Dimer

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).

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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

Ann Arbor, Michigan, 48109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg

Drug

The investigational agent to be used in this study is KSP/QRH dimer: a fluorescently-labeled peptide dimer composed of a 14-amino acid sequence [Lys-Ser-Pro-Asn-Pro-Arg-Phe] and [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a PEG3, Lys and Cys linker [PEG3]2-Lys-Cys to a near-infrared fluorophore, IRDye800CW (0.6 mg dose).

KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg

Drug

The investigational agent to be used in this study is KSP/QRH dimer: a fluorescently-labeled peptide dimer composed of a 14-amino acid sequence [Lys-Ser-Pro-Asn-Pro-Arg-Phe] and [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a PEG3, Lys and Cys linker [PEG3]2-Lys-Cys to a near-infrared fluorophore, IRDye800CW (1.8 mg dose).

Primary outcomes

  1. Number of subjects with abnormal lab values

    Time frame: 48 hours

    review of laboratory values for abnormalities after intervention with KSP/QRH Dimer

  2. Number of subjects with unexpected side effects

    Time frame: 48 hours

    Side effects collected through their follow-up visit

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Phase 1A Study of the Safety of KSP/QRH Dimer in Humans for the Early Detection of GI Malignancies

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 22, 2018
Registry last updated
Nov 6, 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.

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