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Study of the Safety of KSP Heptapeptide (KSP-910638G)

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified June 2017 by Danielle Kim Turgeon, University of Michigan
Sponsor:
Information provided by (Responsible Party):
Danielle Kim Turgeon, University of Michigan
ClinicalTrials.gov Identifier:
NCT03161418
First received: May 18, 2017
Last updated: June 15, 2017
Last verified: June 2017
  Purpose
The purpose of this study is to evaluate the safety of orally administered KSP-910638G, a topically administered li-cor IRDye800CW labeled heptapeptide specific for human epithelial growth factor receptor 2 (HER2).

Condition Intervention Phase
Healthy Adults Drug: KSP-910638G, 0.4 mg Drug: KSP-910638G, 1.2 mg Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
Official Title: Study of the Safety of KSP Heptapeptide (KSP-910638G) in Humans for the Early Detection of GI Malignancies

Further study details as provided by Danielle Kim Turgeon, University of Michigan:

Primary Outcome Measures:
  • Number of subjects with abnormal lab values [ Time Frame: 48 hours ]
    review of laboratory values for abnormalities after intervention with KSP-910638G


Estimated Enrollment: 25
Anticipated Study Start Date: June 26, 2017
Estimated Study Completion Date: December 1, 2017
Estimated Primary Completion Date: December 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KSP-910638G 0.4 mg subjects 1-3
The first three subjects will receive lyophilized powder reconstituted with 5 mL of 0.9% NaCl, 0.4 mg of KSP-910638G total. For the first three subjects, 3.34 mL of KSP-910638G will be discarded. The 1.66 mL of KSP-910638G remaining in the syringe will be administered by squirting it into the mouth of the subject.
Drug: KSP-910638G, 0.4 mg
The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (0.4 mg dose)
Experimental: KSP-910638G 1.2 mg subjects 4-25
Following a safety review of the first three subjects receiving 0.4 mg dose, the remaining 22 subjects will receive the full 1.2 mg dose of KSP-910638G 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-910638G, 1.2 mg
The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (1.2 mg dose)

Detailed Description:

This is a Phase IA study of the safety of an orally administered KSP-910638G heptapeptide 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 1-2 subjects per week, so the study should take about 4-6 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. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted KSP-910638G. 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. 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-910638G ingestion. The study team will conduct a verbal assessment for toxicity at this visit.

  Eligibility

Ages Eligible for Study:   25 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03161418

Contacts
Contact: Danielle K Turgeon, MD 734-764-6860 kturgeon@med.umich.edu
Contact: Elaine M Brady, MBA 734-647-4794 embrady@med.umich.edu

Sponsors and Collaborators
University of Michigan
Investigators
Study Chair: Ashley E Cawthon Michigan Medicine
  More Information

Responsible Party: Danielle Kim Turgeon, Professor of Internal Medicine, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT03161418     History of Changes
Other Study ID Numbers: HUM00126486
Study First Received: May 18, 2017
Last Updated: June 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

ClinicalTrials.gov processed this record on June 23, 2017