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

NCT07617688 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: MODAG-009-P1-02
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MODAG; MODAG GmbH; Synuclein; MSA; Multiple System Atrophy; Parkinson; Parkinson´s disease; PET tracer; MODAG-009

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Incidence and severity of tracer-emergent Adverse events.

  From baseline to 7 (+/-2) business days post-injection of [18F]MODAG-009

Secondary Outcomes (5)

• Biodistribution

  From tracer injection to 6 hours post injection.

• Pharmacokinetics and Whole-body Excretion

  From tracer injection to 6 hours post injection.

• Organ Radiation Dosimetry and Effective Dose

  From tracer injection to 6 hours post injection.

• Pharmacokinetics and Whole-body Excretion

  From tracer injection to 6 hours post injection.

• Organ Radiation Dosimetry and Effective Dose

  From tracer injection to 6 hours post injection.

Study Arms (1)

Healthy Volunteers (HV)

EXPERIMENTAL

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

Drug: [¹⁸F]MODAG-009 PET Imaging

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

Healthy Volunteers (HV)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or Female,
• aged 18 to 60 years old
• in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
• Ability to comply with the study procedures.
• Able to understand and sign written informed consent from the participant.
• Male and Females must meet additional criteria specified below, as applicable
• a. Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of \[18F\]MODAG-009. (i. Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). ii. Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.)
• b. Females of childbearing potential must not be pregnant, breastfeeding or lactating, or planning pregnancy during the duration of the study.
• c. Males with female partners of childbearing potential must use adequate contraceptive methods and refrain from sperm donation for 90 days after injection of \[18F\]MODAG-009

You may not qualify if:

• Use of any prescription drugs, herbal supplements, within four (4) weeks prior to initial dosing, and/or over-the-counter (OTC) medication, dietary supplements (vitamins included) within two (2) weeks prior to initial dosing. If needed (i.e. an incidental and limited need), acetaminophen is acceptable, but must be documented as a concomitant medication / significant non-drug therapy. Participation in any clinical interventional studies within four (4) weeks prior to initial dosing or 5 half-lives of the investigational agent if known and longer than four (4) weeks.
• Participants with a history of exposure to any radiation \>50 mSv/year (e.g., occupational or radiation therapy) over the past year. Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing, or longer if required by local regulation.
• Have a history or presence of any significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders which, in the opinion of the investigator, are capable of altering the absorption, metabolism, or elimination of drugs or posing a health risk to participate in the study.
• Have clinically significant findings on laboratory evaluations.
• Have clinically significant findings on ECG evaluation.
• History of immunodeficiency diseases, including a positive HIV test result.
• A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody test result.
• History of drug or alcohol abuse within the 12 months prior to screening, or evidence of such abuse as indicated by the laboratory assays conducted during the screening.
• History of tobacco product use within 3 months prior to screening, to be verified by urine cotinine screening.
• Positive pregnancy test result, if female.
• Women who are lactating and breastfeeding.

Sponsors & Collaborators

• MODAG GmbH: lead
• Institute for Neurodegenerative Disorders: collaborator
• XingImaging, LLC: collaborator

Study Sites (1)

Institute for Neurodegenerative Disorders and XingImaging, LLC

New Haven, Connecticut, 06510, United States

RECRUITING

MeSH Terms

Conditions

Multiple System Atrophy; Parkinson Disease

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinsonian Disorders

Study Officials

• Neha Prakash, MBBS

  Institute for Neurodegenerative Disorders

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Levin, MD

CONTACT

475-318-8250; levin@modag.net

Stephanie Roman

CONTACT

475-318-8250; sroman@xingimaging.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 1, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 4, 2026

Record last verified: 2026-05

Locations

US (1)