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Granzyme-B targeted-labeled PET radiotracer

Phase 1

Healthy Volunteer | Small molecule | Other |cbdMD, Inc.|Last Updated: Aug 19, 2026

Target and mechanism

ModalitySmall molecule

Also known as Granzyme-B targeted [64Cu]-labeled PET radiotracer

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Granzyme-B targeted-labeled PET radiotracer · 1 trial · 1 indication

Early Phase 1 1
NCT07774650A Study of the Pharmacokinetics, Biodistribution and Dosimetry of Granzyme-B Targeted [Cu-64]-Labeled PET Radiotracers in Adult Healthy VolunteersHealthy Volunteer
RECRUITING12 Analytics
EARLY_PHASE1RECRUITING
A Study of the Pharmacokinetics, Biodistribution and Dosimetry of Granzyme-B Targeted [Cu-64]-Labeled PET Radiotracers in Adult Healthy Volunteers
Healthy Volunteer
NCT0777465012
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Study Endpoints

Primary Endpoints

Determine the maximum concentration (Cmax) of radiation (Pharmacokinetics) in the blood after a single dose of the GzmB-Targeted [Cu-64]-labeled compound
24 hour period post injection.

Blood samples will be collected Pre-dose, immediately post-dose, 45 minutes, 1 \& 4 hours, \& 24 hours post dose. Radiation (PK) to be measured by gamma counter (KBq/mL).

Determine the time to maximum concentration (Tmax) in the blood after a single dose of the GzmB-Targeted [Cu-64]-labeled compound
24 hour period post injection

Blood samples will be collected Pre-dose, immediately post-dose, 45 minutes, 1 \& 4 hours, \& 24 hours post dose. Time to maximum concentration to be measured in hours (h).

Determine the area under the curve (AUC) in blood after a single injection of the GzmB-Targeted [Cu-64]-labeled compound
24 hour period post injection.

Blood samples will be collected Pre-dose, immediately post-dose, 45 minutes, 1 \& 4 hours, \& 24 hours post dose. AUC to be calculated by kilobecquerel x hours/milliliter (KBq x h/mL)

Determine the elimination half-life in the blood post a single injection of the GzmB-Targeted [Cu-64]-labeled compound
24 hour period post injection

Blood samples will be collected Pre-dose, immediately post-dose, 45 minutes, 1 \& 4 hours, \& 24 hours post dose. Elimination to be measured by time to half of the product being excreted from the blood (as measured by gamma counter) in hours (h)

Determine the clearance in the blood after single injection of the GzmB-Targeted [Cu-64]-labeled compound
24 hour period post injection

Blood samples will be collected Pre-dose, immediately post-dose, 45 minutes, 1 \& 4 hours, \& 24 hours post dose. Clearance to be measured by milliliter/minute.

Determine the volume of distribution in the blood after a single injection of the GzmB-Targeted [Cu-64]-labeled compound
24 hour period post injection

Blood samples will be collected Pre-dose, immediately post-dose, 45 minutes, 1 \& 4 hours, \& 24 hours post dose. Volume to be measured by Liter

Evaluate the organ distribution of radioactivity for a single dose of GzmB-targeted [Cu64]-labeled compound
24 hour period post injection

Measuring the uptake in organs from a PET/CT. Imaging timepoints will be collected at 20 minutes post dose, 1 \& 4 hours and 24 hours post dose

Evaluate the safety profile for a single dose of the GzmB-Targeted [Cu-64]-labeled compound in adult healthy volunteers
From injection to 8 days post injection

Determine the incidence, and severity of Treatment Emergent Adverse Events (TEAEs including SAEs).

Secondary Endpoints

Evaluate the radiation absorbed dose estimates for organs for a single dose of the GzmB-Targeted [Cu-64]-labeled compound
24 hour period post injection
Evaluate the whole body effective dose estimated for a single dose of the GzmB-Targeted [Cu-64]-labeled compound
24 hour period post injection
Examine whole-body excretion of a single dose of the GzmB-Targeted [Cu-64] labeled compound
Samples will be taken continuously starting immediately post-dose through 24 hours post injection
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
[Cu-64]RTX-4001EXPERIMENTALArm Description: Single IV administration of \[Cu-64\]RTX-4001, a Granzyme-B-targeted PET radiotracer, in healthy adult volunteers.
[Cu-64]RTX-4002EXPERIMENTALArm Description: Single IV administration of \[Cu-64\]RTX-4002, a Granzyme-B-targeted PET radiotracer, in healthy adult volunteers.

Interventions

NameTypeDescription
Granzyme-B targeted [64Cu]-labeled PET radiotracerDRUGSingle intravenous administration of a Granzyme-B targeted \[64Cu\]-labeled positron emission tomography (PET) radiotracer to assess pharmacokinetics, biodistribution, and radiation dosimetry in adult healthy volunteers.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Adult male or female participants 18-60 years of age judged to be in good health by the Investigator 2. No clinically significant laboratory abnormalities; all tests of liver and kidney function within normal limits 3. Capable of giving signed informed consent, which includes...

Countries:United States
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