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

Healthy Adults Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03643068
• Other study ID #: HUM00141420
• Status: Completed
• Phase: Phase 1
• Start date: August 22, 2018
• Est. completion date: October 27, 2018

Study information

• Verified date: November 2018
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 27, 2018
• Est. primary completion date: October 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Adults

Intervention

Drug:
• KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg
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
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).

Locations

Country	Name	City	State
United States	University of Michigan	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 KSP/QRH Dimer	48 hours
Primary	Number of subjects with unexpected side effects	Side effects collected through their follow-up visit	48 hours