Healthy VolunteersPhase 1NCT05285696
Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.
A Phase 1 study testing CSB-111 in people with Healthy Volunteers, run by Cytosite Biopharma Inc. at 1 site in United States.
Trial summary
Phase one study to evaluate the safety and dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in healthy human volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CSB-111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 20 May 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female healthy participants aged between 18 and 65 years old.
- For females of childbearing potential, a negative serum or urine beta-human chorionic gonadotropin (β-hCG) pregnancy test must be obtained at the day of the procedure prior to CSB-111 administration.
- Willing and able to undergo all study procedures.
- Willing and able to understand the written informed consent and sign the consent document prior to any study-related procedure.
- Willing to refrain from strenuous exercise for the 24 hours prior to CSB-111 administration
Who cannot join
- History of allergic reactions to compounds of similar chemical or biologic composition to CSB-111.
- Prior malignancy except for fully resected skin cancers.
- Current treatment with systemic steroids, or immunosuppressive agents.
- Known renal or hepatic disease.
- Laboratory values:
- Leukocytes <3000/mcL
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- Absolute neutrophil count <1500 mcL
- Platelets <100,000 mcL
- Total bilirubin >1.5 x Upper limit of normal (ULN)
- Aspartate Transaminase (AST)/ Alanine Aminotransferase (ALT) >2.5 x ULN
- Albumin <3.7 g/dL
- Gamma glutamyl transferase (GGT) >2.5 ULN
- eGFR <60 mL/min/1.73 m2 measured in the prior 30 days before administration of CSB-111
- Having received any investigational product in the prior three months of receiving CSB-111.
- Currently participating in any clinical trials, except observational studies.
- Any acute or chronic inflammatory disease, autoimmune disorders, or medical conditions that in the investigator's opinion may interfere with the study procedures or the interpretation of the study results such as infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia.
- Participants who have any condition that would prevent them from receiving a PET scan.
- Female participants who are pregnant (confirmed via a positive serum or urine β-hCG test on the day of procedure prior to CSB-111 administration).
- Female participants who are breastfeeding.
- Unable or unwilling to use adequate contraception prior to study, during study participation and for one week post-injection for both females and males.
- Any medical condition which, in the opinion of the investigator, may interfere with participation in the study and/or alter the biodistribution of CSB-111.
- Mentally incapacitated or unable to understand the informed consent.
- Participants who, in the opinion of the investigator, have underlying psychological conditions which may negatively impact their wellbeing if participating.
- Prisoners.
- Staff and family members of CytoSite.
- Staff reporting to the principal investigator (PI).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.
Phase one study to evaluate the safety and dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in healthy human volunteers.
Read the detailed description
This study aims to assess the safety and evaluate the dosimetry of CSB-111. This study will estimate organ dosimetry and the overall effective dose, a requirement for expanding the human use of a radiopharmaceutical.
- Conditions
- Healthy Volunteers
- Being tested
- CSB-111
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSB-111Drug
Also called [68Ga]-NOTA-hGZP
[68Ga]-NOTA-hGZP is a PET imaging agent.
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]-NOTA-hGZP (CSB-111) Injection | Experimental | Eligible participants will receive a single IV injection of CSB-111 up to 40 micro grams Receives: Drug: CSB-111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Organ-level dosimetry of CSB-111 and total body and effective dose
milli-Sieverts [mSi]
Measured: PET/CT imaging up to 180 minutes post-injection
Percentage of intact CSB-111 in blood samples up to 185 min after injection, using HPLC
Intact CSB-111 percentage in blood
Measured: From 65 to 185 minutes after injection
Total radioactivity via gamma counter of cell pellet, plasma protein and unbound radioactivity in blood samples up to 65 min
milli-Curies [mCi]
Measured: Up to to 185 minutes post dose
Concentration of intact CSB-111 in urine
Intact CSB-111 in urine in picograms
Measured: up to 4 hours after injection or until below the level of detection
Percentage of intact CSB-111 in urine
Percentage of intact CSB-111 in urine compared to initial dose
Measured: up to 4 hours after injection or until below the level of detection
Secondary outcomes (1)
Overall AEs frequency and frequency per grade of AEs related to CSB-111 according to Medical Dictionary for Regulatory Activities (MedDRA)/ Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Overall AEs frequency and frequency per grade of AEs. All AE's in this study will be listed as an endpoint.
Measured: up to 2 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2022
- Study start1 Sep 2022
- Primary completion1 Apr 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytosite Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Colin Miller, Study director, CytoSite Bio Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05285696
- Sponsor's protocol ID
- CYT-002-01
- Status last verified
- May 2023
- First submitted
- 28 Oct 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.
- ClinicalTrials.gov ID
- NCT05285696
- Acronym / sponsor ID
- CYT-002-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cytosite Biopharma Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Alabama at Birmingham
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 17 Mar 2022 (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.
Phase one study to evaluate the safety and dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in healthy human volunteers.
Detailed description
This study aims to assess the safety and evaluate the dosimetry of CSB-111. This study will estimate organ dosimetry and the overall effective dose, a requirement for expanding the human use of a radiopharmaceutical.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]-NOTA-hGZP (CSB-111) Injection | Experimental | Drug: CSB-111Eligible participants will receive a single IV injection of CSB-111 up to 40 micro grams |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female healthy participants aged between 18 and 65 years old.
- For females of childbearing potential, a negative serum or urine beta-human chorionic gonadotropin (β-hCG) pregnancy test must be obtained at the day of the procedure prior to CSB-111 administration.
- Willing and able to undergo all study procedures.
- Willing and able to understand the written informed consent and sign the consent document prior to any study-related procedure.
- Willing to refrain from strenuous exercise for the 24 hours prior to CSB-111 administration
Key exclusion criteria (26 listed)
- History of allergic reactions to compounds of similar chemical or biologic composition to CSB-111.
- Prior malignancy except for fully resected skin cancers.
- Current treatment with systemic steroids, or immunosuppressive agents.
- Known renal or hepatic disease.
- Laboratory values:
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 |
|---|---|---|
| CSB-111Also: [68Ga]-NOTA-hGZP[68Ga]-NOTA-hGZP is a PET imaging agent. | Drug | [68Ga]-NOTA-hGZP (CSB-111) Injection |
Primary outcome
Organ-level dosimetry of CSB-111 and total body and effective dose
Time frame: PET/CT imaging up to 180 minutes post-injection
milli-Sieverts [mSi]
Percentage of intact CSB-111 in blood samples up to 185 min after injection, using HPLC
Time frame: From 65 to 185 minutes after injection
Intact CSB-111 percentage in blood
Total radioactivity via gamma counter of cell pellet, plasma protein and unbound radioactivity in blood samples up to 65 min
Time frame: Up to to 185 minutes post dose
milli-Curies [mCi]
Concentration of intact CSB-111 in urine
Time frame: up to 4 hours after injection or until below the level of detection
Intact CSB-111 in urine in picograms
Percentage of intact CSB-111 in urine
Time frame: up to 4 hours after injection or until below the level of detection
Percentage of intact CSB-111 in urine compared to initial dose
1 secondary outcome
Overall AEs frequency and frequency per grade of AEs related to CSB-111 according to Medical Dictionary for Regulatory Activities (MedDRA)/ Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0
Time frame: up to 2 days post dose
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 9 Aug 2023.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Colin Miller study director
CytoSite Bio Inc.
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 CSB-111 in people with Healthy Volunteers, run by Cytosite Biopharma Inc. 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 5 inclusion and 26 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 9 Aug 2023. 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?
Organ-level dosimetry of CSB-111 and total body and effective dose (time frame: PET/CT imaging up to 180 minutes post-injection). The study lists 5 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 9 Aug 2023.