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CSB-111 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Cytosite Biopharma Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 65 to 185 minutes after injection
Awards & highlights

Study Summary

This trial is testing a new PET scan to see if it is safe and accurate.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 65 to 185 minutes after injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 65 to 185 minutes after injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentration of intact CSB-111 in urine
Organ-level dosimetry of CSB-111 and total body and effective dose
Percentage of intact CSB-111 in blood samples up to 185 min after injection, using HPLC
+2 more
Secondary outcome measures
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
Other outcome measures
Regional (organ) accumulation of CSB-111

Trial Design

1Treatment groups
Experimental Treatment
Group I: [68Ga]-NOTA-hGZP (CSB-111) InjectionExperimental Treatment1 Intervention
Eligible participants will receive a single IV injection of CSB-111 up to 40 micro grams
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSB-111
2022
Completed Phase 1
~10

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cytosite Biopharma Inc.Lead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
University of Alabama at BirminghamOTHER
1,581 Previous Clinical Trials
2,278,023 Total Patients Enrolled
Colin MillerStudy DirectorCytoSite Bio Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the scope of participation in this medical trial?

"Affirmative. The clinicaltrials.gov webpage notes that this medical trial, which was first announced on June 1st 2022, is currently recruiting patients. A total of 10 participants must be sourced from a single location."

Answered by AI

Are geriatric individuals being recruited for this experiment?

"This clinical trial is recruiting individuals who are of mature age (18+) and below retirement age (65)."

Answered by AI

Can I be included as a participant in this medical experiment?

"This medical trial seeks 10 participants between 18-65 years of age who are hale and hearty. Furthermore, individuals must be able to comprehend the consent form and agree to it before any study procedure is conducted. Additionally, a negative pregnancy test must be obtained by female candidates of childbearing potential on the day of treatment prior to CYB-111 administration as well as being willing and capable of completing all clinical tests related to this project."

Answered by AI

Is CSB-111 a viable health solution for those seeking relief?

"Due to the fact that this is a Phase 1 medical trial, our team at Power rated CSB-111's safety as a 1. This rating was given because there is only limited data available demonstrating its efficacy and security."

Answered by AI

Can new participants join this research study?

"Affirmative. The records present on ClinicalTrials.gov manifest that this clinical experiment, which was introduced to the public on June 1st 2022, is actively searching for participants. 10 people need to be sought from a single medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.
2022. "Study to Evaluate the Safety and Dosimetry of [68Ga]-NOTA-hGZP (CSB-111) PET Imaging in Healthy Human Volunteers.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05285696.
~2 spots leftby Apr 2025
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