RecruitingAmyotrophic Lateral Sclerosis (ALS)Parkinson Disease (PD)Alzheimer Disease (AD)
Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers
Eligible age
18–80 yrs
Accepts
All genders
Locations
2 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: Ashvattha Therapeutics, Inc.
You may qualify if…
- ✓ 1. Has the ability to understand and sign the written ICF and local medical privacy authorization forms, which must be obtained prior to the conduct of any study related procedures.
- ✓ 2. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the local laboratory's defined ranges.
- ✓ 3. Female subjects of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male subjects must agree to practice abstinence from sexual intercourse or use a medically accepted contraceptive regimen (including hormonal contraceptives) during their participation in the study and for 90 days (males) or 6 months (females) after Day 1. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy and are as follows:
- ✓ 1. Male subjects: condoms or surgical sterilization of subject at least 26 weeks before the Screening Visit (i.e., vasectomy).
- ✓ 2. Female subjects:
- ✓ 1. Surgical sterilization at least 26 weeks before the Screening Visit (includes hysterectomy or bilateral tubal ligation, bilateral oophorectomy, or salpingectomy);
- ✓ 2. Intrauterine device or diaphragm with spermicide for at least 12 weeks before the Screening Visit; or
- ✓ 3. Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks before the Screening Visit.
You may not qualify if…
- ✕ 19. Clinical signs or laboratory findings suggestive of neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e., presence of anti-NMO \[aquaporin-4\] antibodies or anti-MOG antibodies)
- ✕ 20. Diagnosis of progressive multifocal leukoencephalopathy (PML)
- ✕ 21. Secondary, atypical, or genetic parkinsonism
- ✕ 22. Clinically relevant finding on physical examination at Screening
- ✕ 23. Family history of neurological disease that may confound interpretation of imaging results
- ✕ 24. History of any central nervous system disorder or brain trauma that could cause imaging abnormalities in the opinion of the Principal Investigator and Medical Monitor
Where it's recruiting
California
San Francisco · Stanford
Florida
Jacksonville
Source: ClinicalTrials.gov · NCT05395624 · last updated 2025-05-02