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

NCT03643068 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-11-06

No results posted yet for this study

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

Interventions

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).

DRUG

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).

Sponsors & Collaborators

Principal Investigators

  • Deepa Chandhrasekhar, BS · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2018-10-27
Completion
2018-10-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643068 on ClinicalTrials.gov