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

NCT03161418 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: HUM00126486
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (1)

• Number of subjects with abnormal lab values

  review of laboratory values for abnormalities after intervention with KSP-910638G

  48 hours

Study Arms (2)

KSP-910638G 0.4 mg subjects 1-3

EXPERIMENTAL

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

KSP-910638G 1.2 mg subjects 4-25

EXPERIMENTAL

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

Interventions

KSP-910638G, 0.4 mg DRUG

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)

KSP-910638G 0.4 mg subjects 1-3

KSP-910638G, 1.2 mg DRUG

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)

KSP-910638G 1.2 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

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

Study Officials

• Ashley E Cawthon

  Michigan Medicine

  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, Medical School

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 19, 2017
• Study Start: June 21, 2017
• Primary Completion: September 20, 2017
• Study Completion: September 20, 2017
• Last Updated: December 5, 2017

Record last verified: 2017-12

Locations

US (1)