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

Completed · Phase 1

Conditions studied: Healthy Adults

In brief

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).

Key facts

Study ID

NCT03643068

Run by

University of Michigan

People needed

26

Starts

2018-08-22

Expected to finish

2018-10-27

Last updated by the study team

2018-11-06

Who can join

Age: 25 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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