A Study of the Pharmacokinetics, Biodistribution and Dosimetry of Granzyme-B Targeted [Cu-64]-Labeled PET Radiotracers in Adult Healthy Volunteers

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Ratio Therapeutics, Inc.
Study ID
NCT07774650
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Granzyme-B targeted [64Cu]-labeled PET radiotracer — DRUG
    Single 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.

Study Details

This is an exploratory clinical study of copper-64 \[Cu-64\]-labeled granzyme B (GzmB)-targeted compounds for PET/CT imaging. The goal is to determine how GzmB-Targeted \[Cu-64\]-labeled compounds are distributed in the body by assessing PET/CT images and blood samples, and to assess the safety profile after a single intravenous dose. Up to 6 healthy volunteers (3 female, 3 male) will receive one injection of a GzmB-targeted \[Cu-64\]-labeled compound, then undergo multiple whole-body PET/CT scans, blood and urine tests over about 24 hours, and a follow-up phone call around Day 7. Up to 2 GzmB-Targeted \[Cu-64\]-labeled compounds may be assessed (i.e. maximum of 12 healthy volunteers in total in the study). Researchers will look at the blood activity of GzmB-Targeted \[Cu-64\]-labeled compound and the organ distribution and movement of the product in the body. They will also evaluate any changes in physical examination assessments, vital signs, ECG, and clinical laboratory measurements from pre-administration to post-administration.

Key Dates

First listed
Aug 19, 2026
Start date
Jul 8, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC

Arms

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

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Xing ImagingNew HavenConnecticut06510-

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Xing Imaging· New Haven, CT

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