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

NCT03643068 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: HUM00141420
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Number of subjects with abnormal lab values

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

  48 hours

• Number of subjects with unexpected side effects

  Side effects collected through their follow-up visit

  48 hours

Study Arms (2)

KSP-QRH-E3-IRDye800 (Peptide 919288G) 0.6 mg subjects 1-3

EXPERIMENTAL

The first three subjects will receive lyophilized powder reconstituted with 5 mL of 0.9% NaCl, 0.6 mg of KSP-QRH-E3-IRDye800 (Peptide 919288G) total. For the first three subjects, 3.34 mL of KSP-QRH-E3-IRDye800 (Peptide 919288G)will be discarded. The 1.66 mL of KSP-QRH-E3-IRDye800 (Peptide 919288G)remaining in the syringe will be administered by squirting it into the mouth of the subject.

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

KSP-QRH-E3-IRDye800 (Peptide 919288G) 1.8 mg subjects 4-25

EXPERIMENTAL

Following a safety review of the first three subjects receiving 0.6 mg dose, the remaining 22 subjects will receive the full 1.8 mg dose of KSP-QRH-E3-IRDye800 (Peptide 919288G) reconstituted in 5 mL 0.9% NaCl. These 22 subjects will receive all 5 mL of the peptide solution in a syringe for administration. The agent will not be reconstituted until the subject is ready to squirt the peptide into his or her mouth via syringe. They will be asked to wait 5 minutes and then drink at least 4-8 oz of tap water.

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

Interventions

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) 0.6 mg subjects 1-3

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).

KSP-QRH-E3-IRDye800 (Peptide 919288G) 1.8 mg subjects 4-25

Eligibility Criteria

• Age: 25 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Peptides

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Deepa Chandhrasekhar, BS

  University of Michigan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: August 22, 2018
• Primary Completion: October 27, 2018
• Study Completion: October 27, 2018
• Last Updated: November 6, 2018

Record last verified: 2018-11

Locations

US (1)