Actively Recruiting
Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers
Led by Ashvattha Therapeutics, Inc. · Updated on 2025-05-02
65
Participants Needed
3
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1/2 study to evaluate the safety and tolerability of 18F-OP-801 in subjects with ALS, AD, MS, PD and age-matched HVs. 18F-OP-801 is intended as a biomarker for PET imaging of activated microglia and macrophages in regions of neuroinflammation.
CONDITIONS
Official Title
Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent and privacy forms
- Female participants of non-childbearing potential must be surgically sterile or postmenopausal
- Females of childbearing potential and all males must agree to use medically accepted contraception or abstinence during study and follow-up
- Male subjects must abstain from sperm donation during study and 90 days after Day 1
- Female subjects may not be pregnant, lactating, or breastfeeding
- Female subjects of childbearing potential must have negative pregnancy tests at screening and check-in
- Estimated glomerular filtration rate (eGFR) above 45 mL/min/1.73m2 at screening
- C-reactive protein level at or below 10 mg/dL
- Willingness and ability to comply with all study requirements
- ALS subjects aged 18 to 80 with diagnosed ALS according to modified El Escorial criteria
- ALS subjects must have forced vital capacity of 50% or greater or be able to lie flat for up to 90 minutes
- AD subjects aged 40 to 80 with clinical diagnosis of early stage Alzheimer's dementia and positive biomarkers
- AD subjects must have MMSE score above 20 at screening
- MS subjects aged 18 to 70 with diagnosis and medication changes discussed with Medical Monitor
- RRMS subjects must meet 2017 McDonald criteria and have documented relapse or MRI lesions as specified
- Progressive MS subjects must meet 2017 McDonald criteria with disability scores and no relapse in prior 6 months
- PD subjects aged 55 to 80 with diagnosis of definite idiopathic Parkinson's disease
- PD medication changes discussed with Medical Monitor
You will not qualify if you...
- Body weight over 120 kg
- Significant past or current medical conditions affecting drug metabolism or safety as judged by investigator
- History of recurrent kidney or liver cancer
- Pacemaker, defibrillator, or incompatible metallic implants
- Inability to lie still in PET/CT or PET/MRI scanner for up to 90 minutes
- Clinically significant abnormal laboratory results at screening or check-in
- Recent acute illness within 10 days before screening
- History of alcoholism or drug abuse within 2 years prior to screening
- Positive drug or cotinine tests at screening or check-in
- Recent immunizations within 28 days prior to screening
- Use of other investigational drugs within 30 days or 5 half-lives before Day 1
- Corticosteroid treatment within 30 days before baseline
- Use of certain NSAIDs within 14 days before Day 1
- Significant blood loss or donation within 30 days before screening
- MRI or CT findings that interfere with imaging interpretation
- Investigator judgment of inability to meet study schedule or safety concerns
- MS-specific exclusions including neuromyelitis optica, MOG encephalomyelitis, or PML
- PD-specific exclusions including secondary, atypical, or genetic parkinsonism
- Healthy volunteer exclusions including relevant neurological findings, family history, or CNS disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
UCSF
San Francisco, California, United States, 94107
Actively Recruiting
2
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
3
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
J
Julee Cheung
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
5
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