Healthy AdultEarly Phase 1NCT07617688
Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers
A Early Phase 1 study testing [¹⁸F]MODAG-009 PET Imaging in people with Healthy Adult, run by MODAG GmbH at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult
- What is being tested?
- [¹⁸F]MODAG-009 PET Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2026to May 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Institute for Neurodegenerative Disorders and XingImaging, LLC
New Haven, Connecticut, 06510
Stephanie Roman, 475-318-8250, sroman@xingimaging.com
Neha Prakash, MBBS
About this study
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.
Read the detailed description
This is an open-label, single-center, phase 1 study to further characterize [18F]MODAG-009 in HVs.
All eligible participants receive a single intravenous (IV) injection of [¹⁸F]MODAG-009 followed by whole-body PET imaging in up to 3 imaging sessions for up to 6 hours post-injection, according to an Image Acquisition Plan (IAP). Safety assessments include physical examination, vital signs, ECG, safety laboratory tests, and AE monitoring on the imaging day and at a follow-up contact 7 (+/-2) business days after tracer injection. Blood and urine sampling is performed for radiometabolite analysis and urinary radioactivity respectively, as specified in the IAP.
Approximately 6 participants will be enrolled in this study. The target enrollment will be HVs.
- Conditions
- Healthy Adult
- Being tested
- [¹⁸F]MODAG-009 PET Imaging
- Keywords
- MODAG, MODAG GmbH, Synuclein, MSA, Multiple System Atrophy, Parkinson, Parkinson´s disease, PET tracer, MODAG-009
- Medical subject headings
- Multiple System Atrophy, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁸F]MODAG-009 PET ImagingDrug
Participants enrolled in the study will receive a single intravenous (IV) dose of [¹⁸F]MODAG-009 administered prior to PET imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: [¹⁸F]MODAG-009 PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence and severity of tracer-emergent Adverse events.
Measured: From baseline to 7 (+/-2) business days post-injection of [18F]MODAG-009
Secondary outcomes (5)
Biodistribution
Organ distribution and tissue kinetics of radioactivity.
Measured: From tracer injection to 6 hours post injection.
Pharmacokinetics and Whole-body Excretion
Radiation absorbed dose estimates for organs
Measured: From tracer injection to 6 hours post injection.
Organ Radiation Dosimetry and Effective Dose
Whole body effective dose estimate.
Measured: From tracer injection to 6 hours post injection.
Pharmacokinetics and Whole-body Excretion
Blood metabolite characterization of [18F]MODAG-009 to determine metabolite fate and nature of metabolites.
Measured: From tracer injection to 6 hours post injection.
Organ Radiation Dosimetry and Effective Dose
Quantitative assessment of excretion of [18F]MODAG-009 and metabolites via urine.
Measured: From tracer injection to 6 hours post injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start27 May 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MODAG GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- XingImaging, LLC, Institute for Neurodegenerative Disorders
- Responsible party
- Sponsor
- Investigators
- Neha Prakash, MBBS, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07617688
- Sponsor's protocol ID
- MODAG-009-P1-02
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics, Biodistribution and Radiation Dosimetry of [18F]MODAG-009 Positron Emission Tomography (PET) Radiotracers in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT07617688
- Acronym / sponsor ID
- MODAG-009-P1-02
- Conditions
- Healthy Adult
- Keywords
- MODAG, MODAG GmbH, Synuclein, MSA, Multiple System Atrophy, Parkinson, Parkinson´s disease, PET tracer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- MODAG GmbHIndustry (pharma, biotech, devices)
- Collaborators
- XingImaging, LLC, Institute for Neurodegenerative Disorders
- Study start
- 27 May 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, single-center, phase 1 study to further characterize [18F]MODAG-009 in HVs.
All eligible participants receive a single intravenous (IV) injection of [¹⁸F]MODAG-009 followed by whole-body PET imaging in up to 3 imaging sessions for up to 6 hours post-injection, according to an Image Acquisition Plan (IAP). Safety assessments include physical examination, vital signs, ECG, safety laboratory tests, and AE monitoring on the imaging day and at a follow-up contact 7 (+/-2) business days after tracer injection. Blood and urine sampling is performed for radiometabolite analysis and urinary radioactivity respectively, as specified in the IAP.
Approximately 6 participants will be enrolled in this study. The target enrollment will be HVs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers (HV) | Experimental | Drug: [¹⁸F]MODAG-009 PET ImagingParticipants enrolled in the study will receive a single intravenous (IV) dose of [¹⁸F]MODAG-009 administered prior to PET imaging. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [¹⁸F]MODAG-009 PET ImagingParticipants enrolled in the study will receive a single intravenous (IV) dose of [¹⁸F]MODAG-009 administered prior to PET imaging | Drug | Healthy Volunteers (HV) |
Primary outcome
Safety and Tolerability
Time frame: From baseline to 7 (+/-2) business days post-injection of [18F]MODAG-009
Incidence and severity of tracer-emergent Adverse events.
5 secondary outcomes
Biodistribution
Time frame: From tracer injection to 6 hours post injection.
Pharmacokinetics and Whole-body Excretion
Time frame: From tracer injection to 6 hours post injection.
Organ Radiation Dosimetry and Effective Dose
Time frame: From tracer injection to 6 hours post injection.
Pharmacokinetics and Whole-body Excretion
Time frame: From tracer injection to 6 hours post injection.
Organ Radiation Dosimetry and Effective Dose
Time frame: From tracer injection to 6 hours post injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neha Prakash, MBBS principal investigator
Institute for Neurodegenerative Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing [¹⁸F]MODAG-009 PET Imaging in people with Healthy Adult, run by MODAG GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johannes Levin, MD (475-318-8250, levin@modag.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: From baseline to 7 (+/-2) business days post-injection of [18F]MODAG-009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.