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

Overview

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.

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

Primary outcome measures

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

Secondary outcome measures (5)

• 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Institute for Neurodegenerative Disorders and XingImaging, LLC — New Haven

Identifiers

NCT: NCT07617688 · MODAG-009-P1-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗