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

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
MODAG GmbH
Study ID
NCT07617688
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

  • Healthy Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 27, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
6 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

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

Primary Outcome Measure

Safety and Tolerability [ Time Frame: From baseline to 7 (+/-2) business days post-injection of [18F]MODAG-009 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Institute for Neurodegenerative Disorders and XingImaging, LLCNew HavenConnecticut06510
Stephanie Roman
[email protected]
475-318-8250
Neha Prakash, MBBS (PRINCIPAL_INVESTIGATOR)

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By research site
Institute for Neurodegenerative Disorders and XingImaging, LLC· New Haven, CT

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