Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers

Recruiting now · Phase 1/Phase 2

Conditions studied: Amyotrophic Lateral Sclerosis (ALS), Parkinson Disease (PD), Alzheimer Disease (AD), Multiple Sclerosis (MS)

In brief

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.

Key facts

Study ID: NCT05395624
Run by: Ashvattha Therapeutics, Inc.
People needed: 65
Starts: 2023-02-02
Expected to finish: 2026-05-01
Last updated by the study team: 2025-05-02

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.
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.
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:
Male subjects: condoms or surgical sterilization of subject at least 26 weeks before the Screening Visit (i.e., vasectomy).
Female subjects:
Surgical sterilization at least 26 weeks before the Screening Visit (includes hysterectomy or bilateral tubal ligation, bilateral oophorectomy, or salpingectomy);
Intrauterine device or diaphragm with spermicide for at least 12 weeks before the Screening Visit; or
Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks before the Screening Visit.
If male, subjects must agree to abstain from sperm donation through 90 days after the Day 1 Visit.
Female subjects may not be pregnant, lactating, or breastfeeding.
Female subjects of childbearing potential must have negative result for pregnancy test at Screening and Check-in.
Subjects must have an estimated glomerular filtration rate (eGFR) of >45 mL/min/1.73m2 at Screening.
C-reactive protein level ≤10 mg/dL.
Subjects must be willing and able to abide by all study requirements and restrictions.
Inclusion Criteria Specific to ALS Subjects:
Adult (Age 18 to 80, inclusive) at the Screening Visit
Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by the modified El Escorial criteria.
Forced vital capacity (FVC) of ≥50%; or if in the opinion of the investigator can lay flat for up to 90 minutes. If FVC has been performed within the past 6 months, this data may be used at the discretion of the investigator.
For ALS subjects, medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.
Inclusion Criteria Specific to AD Subjects
Adult (Age 40 to 80, inclusive) at the Screening Visit
Clinical diagnosis of early stage dementia, Alzheimer type, plus positive Aβ and tau PET imaging, cerebrospinal fluid (CSF) and/or plasma biomarkers consistent with 2018 NIA-AA criteria
MMSE score >20 at Screening
AD medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.
Inclusion Criteria Specific to MS Subjects:

Where it is running

UCSF — San Francisco, California, United States (enrolling)
Stanford University — Stanford, California, United States (enrolling)
Mayo Clinic Jacksonville — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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