Healthy AdultsPhase 1NCT03643068
Phase 1A Study of the Safety of KSP/QRH Dimer
A Phase 1 study testing KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg and KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg in people with Healthy Adults, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg and KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2018to 27 Oct 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 1A Study of the Safety of KSP/QRH Dimer in Humans for the Early Detection of GI Malignancies
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).
Read the detailed description
This is a Phase IA study of the safety of an orally administered KSP-QRH-E3-IRDye800 (Peptide 919288G) heptapeptide dimer 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 2-3 subjects per week, so the study should take about 2-3 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, as well as have an EKG. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted KSP-QRH-E3-IRDye800 (Peptide 919288G). 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, and another EKG will be conducted. 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-QRH-E3-IRDye800 (Peptide 919288G) ingestion. The study team will conduct a verbal assessment for toxicity at this visit.
- Conditions
- Healthy Adults
- Being tested
- KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg, KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mgDrug
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), 1.8 mgDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with abnormal lab values
review of laboratory values for abnormalities after intervention with KSP/QRH Dimer
Measured: 48 hours
Number of subjects with unexpected side effects
Side effects collected through their follow-up visit
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start22 Aug 2018
- Primary completion27 Oct 2018
- Study completion27 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danielle Kim Turgeon, University of Michigan
- Investigators
- Deepa Chandhrasekhar, BS, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643068
- Sponsor's protocol ID
- HUM00141420
- Status last verified
- Nov 2018
- First submitted
- 20 Aug 2018
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1A Study of the Safety of KSP/QRH Dimer in Humans for the Early Detection of GI Malignancies
- ClinicalTrials.gov ID
- NCT03643068
- Acronym / sponsor ID
- HUM00141420
- Conditions
- Healthy Adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- 27 Oct 2018 (actual)
- Study completion
- 27 Oct 2018 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a Phase IA study of the safety of an orally administered KSP-QRH-E3-IRDye800 (Peptide 919288G) heptapeptide dimer 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 2-3 subjects per week, so the study should take about 2-3 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, as well as have an EKG. A negative urine pregnancy test for women of child-bearing potential is required to be eligible. Eligible subjects will consume the reconstituted KSP-QRH-E3-IRDye800 (Peptide 919288G). 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, and another EKG will be conducted. 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-QRH-E3-IRDye800 (Peptide 919288G) ingestion. The study team will conduct a verbal assessment for toxicity at this visit.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KSP-QRH-E3-IRDye800 (Peptide 919288G) 0.6 mg subjects 1-3 | Experimental | Drug: KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mgThe 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. |
| KSP-QRH-E3-IRDye800 (Peptide 919288G) 1.8 mg subjects 4-25 | Experimental | Drug: KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mgFollowing 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. |
Who may qualify
- Ages
- 25 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mgThe 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) 0.6 mg subjects 1-3 |
| KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mgThe 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). | Drug | KSP-QRH-E3-IRDye800 (Peptide 919288G) 1.8 mg subjects 4-25 |
Primary outcome
Number of subjects with abnormal lab values
Time frame: 48 hours
review of laboratory values for abnormalities after intervention with KSP/QRH Dimer
Number of subjects with unexpected side effects
Time frame: 48 hours
Side effects collected through their follow-up visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepa Chandhrasekhar, BS study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg and KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg in people with Healthy Adults, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with abnormal lab values (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2018.