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Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers

NCT07617688 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-06-04

No results posted yet for this study

Summary

This is an open-label, single-center, phase 1 study to further characterize \[18F\]MODAG-009 in Healthy Volunteers (HV). Approximately 6 participants will be enrolled in this study. Each participant will receive a single dose of \[18F\]MODAG-009 radiotracer and undergo whole body PET imaging covering up to 10 bed positions to capture the whole body from skull vertex to mid-thigh.

Conditions

  • Healthy Adult

Interventions

DRUG

[¹⁸F]MODAG-009 PET Imaging

Participants enrolled in the study will receive a single intravenous (IV) dose of \[¹⁸F\]MODAG-009 administered prior to PET imaging

Sponsors & Collaborators

  • XingImaging, LLC

    collaborator INDUSTRY

  • Institute for Neurodegenerative Disorders

    collaborator OTHER

  • MODAG GmbH

    lead INDUSTRY

Principal Investigators

  • Neha Prakash, MBBS · Institute for Neurodegenerative Disorders

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-27
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07617688 on ClinicalTrials.gov