Recruiting
Early Phase 1

\[18F\]MODAG-009

Sponsor:

MODAG GmbH

Code:

NCT07617688

Conditions

Healthy Adult

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

[¹⁸F]MODAG-009 PET Imaging

Study Details

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

Study ID

NCT07617688

Start date

May 27, 2026

Status verified date

May, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

6 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

[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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Johannes Levin, MD

475-318-8250levin@modag.net

Stephanie Roman

475-318-8250sroman@xingimaging.com

Locations

Institute for Neurodegenerative Disorders and XingImaging, LLC

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Stephanie Roman

475-318-8250sroman@xingimaging.com

Principal Investigator:

Neha Prakash, MBBS

More Information

Sponsor

MODAG GmbH

Last update posted

Jun 4, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MODAG GmbH on 2026-06-04.