RECRUITING

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

Conditions

Amyotrophic Lateral Sclerosis (ALS)Parkinson Disease (PD)Alzheimer Disease (AD)Multiple Sclerosis (MS)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2 Study to Evaluate Safety, PK and Biodistribution of an Imaging Agent, 18F-OP-801, After Intravenous Administration to Patients With ALS, Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease and Healthy Volunteers

Quick Facts

Study Start:2023-02-02

Study Completion:2025-03-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05395624

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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. 4. If male, subjects must agree to abstain from sperm donation through 90 days after the Day 1 Visit. 5. Female subjects may not be pregnant, lactating, or breastfeeding. 6. Female subjects of childbearing potential must have negative result for pregnancy test at Screening and Check-in. 7. Subjects must have an estimated glomerular filtration rate (eGFR) of \>45 mL/min/1.73m2 at Screening. 8. C-reactive protein level ≤10 mg/dL. 9. Subjects must be willing and able to abide by all study requirements and restrictions. 10. Adult (Age 18 to 80, inclusive) at the Screening Visit 11. Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by the modified El Escorial criteria. 12. 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. 13. For ALS subjects, medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor. 14. Adult (Age 40 to 80, inclusive) at the Screening Visit 15. 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 16. MMSE score \>20 at Screening 17. AD medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor. 18. Adult (Age 18 to 70, inclusive) at the Screening Visit 19. MS medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor. 20. Diagnosis of RRMS based on 2017 McDonald criteria 21. If not newly diagnosed, subjects should have at least 1 documented relapse in the last 24 months. 22. "Active disease" subjects should have at least 1 Gadolinium-enhancing (Gd+) T1-weighted brain or spinal cord lesion at Screening MRI. 23. "Disease in remission" subjects should have no Gd+ T1-weighted brain or spinal cord lesions at Screening MRI and stable clinical symptoms for at least 3 months prior to Day 1. 24. EDSS score between 2.0 and 5.5 inclusive at Screening 25. Diagnosis of PPMS or SPMS based on 2017 McDonald criteria 26. EDSS score between 3.0 and 6.5 inclusive at Screening 27. No evidence of relapse in the prior 6 months 28. Neurological exam and symptom stability for ≥30 days prior to Day 1 29. Documented evidence of disability progression in the past 24 months not temporally related to a relapse 30. Adult (Age 55 to 80, inclusive) at the Screening Visit 31. Diagnosis of definite, idiopathic Parkinson's disease according to UK Parkinson's Society Brain Bank diagnostic criteria 32. PD medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor. 1. Body weight \>120 kg 2. Evidence of clinically significant or past medical history of hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies) or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism or excretion of study drug or place the subject at an unacceptable risk as a participant in this study 3. History of recurrent kidney or liver malignancy 4. Pacemaker or defibrillator or any non-removable metallic foreign objects in the body not compatible with MRI 5. Inability to lie in a PET/CT or PET/MRI scanner for up to 90 minutes at a time 6. Laboratory results (serum chemistry, hematology, coagulation and urinalysis) outside the normal range at Screening and Check-In and considered clinically significant in the opinion of the Investigator. Any elevation of aspartate transaminase (AST) and alanine transaminase (ALT) more than 3 times above the upper limit of normal at screening and/or check-in is exclusionary. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator and with approval from the Medical Monitor. 7. Resolved acute illness considered clinically significant by the Investigator within 10 days prior to Screening 8. History of alcoholism or drug abuse within 2 years prior to Screening. No cannabinoid drug use for at least 10 days prior to Day 1. 9. Positive urine drug test, marijuana test or cotinine test at Screening or Check-In 10. Any immunizations within the 28 days prior to screening 11. Received any other investigational medicinal product within 30 days or 5 half-lives (whichever is longer) prior to Day 1 12. Corticosteroid treatment (e.g., prednisone, solumedrol) within 30 days of Baseline 13. Treatment with any of the following classes of nonsteroidal anti-inflammatory drugs (NSAIDS): carboxylic acids, enolic acids, cyclooxygenase (COX) II inhibitors within 14 days of Day 1 14. Lost or donated \>450 mL of whole blood or blood products within 30 days prior to Screening 15. MRI	16. CT exclusion criteria include any medical device or metallic implant that may interfere with image acquisition or affect image reconstruction (e.g., CT attenuation correction). 17. Investigator has reason to believe that the subject may be unable to fulfill the protocol visit schedule or requirements 18. Has any finding that, in the view of the Investigator and Medical Monitor, would compromise the subject's safety in the trial 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

Inclusion Criteria

Exclusion Criteria

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.
4. If male, subjects must agree to abstain from sperm donation through 90 days after the Day 1 Visit.
5. Female subjects may not be pregnant, lactating, or breastfeeding.
6. Female subjects of childbearing potential must have negative result for pregnancy test at Screening and Check-in.
7. Subjects must have an estimated glomerular filtration rate (eGFR) of \>45 mL/min/1.73m2 at Screening.
8. C-reactive protein level ≤10 mg/dL.
9. Subjects must be willing and able to abide by all study requirements and restrictions.
10. Adult (Age 18 to 80, inclusive) at the Screening Visit
11. Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by the modified El Escorial criteria.
12. 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.
13. For ALS subjects, medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.
14. Adult (Age 40 to 80, inclusive) at the Screening Visit
15. 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
16. MMSE score \>20 at Screening
17. AD medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.
18. Adult (Age 18 to 70, inclusive) at the Screening Visit
19. MS medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.
20. Diagnosis of RRMS based on 2017 McDonald criteria
21. If not newly diagnosed, subjects should have at least 1 documented relapse in the last 24 months.
22. "Active disease" subjects should have at least 1 Gadolinium-enhancing (Gd+) T1-weighted brain or spinal cord lesion at Screening MRI.
23. "Disease in remission" subjects should have no Gd+ T1-weighted brain or spinal cord lesions at Screening MRI and stable clinical symptoms for at least 3 months prior to Day 1.
24. EDSS score between 2.0 and 5.5 inclusive at Screening
25. Diagnosis of PPMS or SPMS based on 2017 McDonald criteria
26. EDSS score between 3.0 and 6.5 inclusive at Screening
27. No evidence of relapse in the prior 6 months
28. Neurological exam and symptom stability for ≥30 days prior to Day 1
29. Documented evidence of disability progression in the past 24 months not temporally related to a relapse
30. Adult (Age 55 to 80, inclusive) at the Screening Visit
31. Diagnosis of definite, idiopathic Parkinson's disease according to UK Parkinson's Society Brain Bank diagnostic criteria
32. PD medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.
1. Body weight \>120 kg
2. Evidence of clinically significant or past medical history of hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or clinically significant drug allergies) or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism or excretion of study drug or place the subject at an unacceptable risk as a participant in this study
3. History of recurrent kidney or liver malignancy
4. Pacemaker or defibrillator or any non-removable metallic foreign objects in the body not compatible with MRI
5. Inability to lie in a PET/CT or PET/MRI scanner for up to 90 minutes at a time
6. Laboratory results (serum chemistry, hematology, coagulation and urinalysis) outside the normal range at Screening and Check-In and considered clinically significant in the opinion of the Investigator. Any elevation of aspartate transaminase (AST) and alanine transaminase (ALT) more than 3 times above the upper limit of normal at screening and/or check-in is exclusionary. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator and with approval from the Medical Monitor.
7. Resolved acute illness considered clinically significant by the Investigator within 10 days prior to Screening
8. History of alcoholism or drug abuse within 2 years prior to Screening. No cannabinoid drug use for at least 10 days prior to Day 1.
9. Positive urine drug test, marijuana test or cotinine test at Screening or Check-In
10. Any immunizations within the 28 days prior to screening
11. Received any other investigational medicinal product within 30 days or 5 half-lives (whichever is longer) prior to Day 1
12. Corticosteroid treatment (e.g., prednisone, solumedrol) within 30 days of Baseline
13. Treatment with any of the following classes of nonsteroidal anti-inflammatory drugs (NSAIDS): carboxylic acids, enolic acids, cyclooxygenase (COX) II inhibitors within 14 days of Day 1
14. Lost or donated \>450 mL of whole blood or blood products within 30 days prior to Screening
15. MRI

16. CT exclusion criteria include any medical device or metallic implant that may interfere with image acquisition or affect image reconstruction (e.g., CT attenuation correction).
17. Investigator has reason to believe that the subject may be unable to fulfill the protocol visit schedule or requirements
18. Has any finding that, in the view of the Investigator and Medical Monitor, would compromise the subject's safety in the trial
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

Contacts and Locations

Study Contact

Sarah Thayer

CONTACT

650-505-5042

sthayer@avttx.com

Principal Investigator

Farshad Moradi, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

UCSF

San Francisco, California, 94107

United States

Stanford University

Stanford, California, 94305

United States

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

United States

Collaborators and Investigators

Sponsor: Ashvattha Therapeutics, Inc.

Farshad Moradi, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-02

Study Completion Date2025-03-01

Study Record Updates

Study Start Date2023-02-02

Study Completion Date2025-03-01

Terms related to this study

Additional Relevant MeSH Terms

Amyotrophic Lateral Sclerosis (ALS)
Parkinson Disease (PD)
Alzheimer Disease (AD)
Multiple Sclerosis (MS)