[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ashvattha Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100621402","phase-1-study-evaluating-safety--tolerability-of-migaldendranib-in-healthy-volunteers-100621402",false,"NCT07370155","Study Evaluating Safety & Tolerability of Migaldendranib in Healthy Volunteers","A Phase 1, Open-Label, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Migaldendranib (MGB) in Healthy Volunteers","Inclusion Criteria:\n\n1. Healthy man or woman age 18 to 65 years, inclusive, at the Screening Visit\n2. Has the ability to understand and sign the written ICF and local medical privacy authorization forms, which must be obtained prior to any study-related procedures being completed\n3. Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, and laboratory profile, as judged by the Investigator\n4. Female participants of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and\u002For bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 1 year, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the central laboratory's ranges\n5. All female participants of childbearing potential with male partners and male participants with female partners of childbearing potential must consent to use 2 (two) highly effective methods of contraception from start of study and for at least 90 days following the EOS visit or last dose of study treatment, whichever is later. Women of childbearing potential on hormonal contraceptives must be stable on the medication for at least 2 menstrual cycles prior to Day -1.\n\n   The following are acceptable methods of highly effective contraception:\n   * Using twice the normal protection of birth control by using a condom AND one other form of contraception; either birth control pills (The Pill), or injectable birth control, birth control patch or contraceptive implant associated with inhibition of ovulation, or intrauterine device; or\n   * Surgical sterilization as a single form of birth control: i.e., tubal ligation, hysterectomy, bilateral oophorectomy, vasectomy, or equivalently effective surgical form of birth control (with documented proof of the absence of sperm in the post-vasectomy ejaculate) at least 6 months prior to screening; or\n   * True sexual abstinence for the duration of the study and for at least 12 weeks following the EOS visit or after the last dose of IP, whichever is later, is acceptable only when in line with the preferred and usual lifestyle of the participant.\n   * Periodic abstinence (calendar, symptothermal, post ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea methods are not considered \"true\" abstinence and are not acceptable methods of contraception.\n6. If male, participants must agree to abstain from sperm donation through 90 days after administration of the last dose of study drug\n7. If female, participants must refrain from donation of ova from start of study and for 120 days after last dose of investigational drug\n8. Female participants may not be pregnant, lactating, or breastfeeding\n9. Female participants of childbearing potential must have a negative pregnancy test at screening and Check-in (Day -1)\n10. Participants must have a negative test result for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVab), and human immunodeficiency virus (HIV) antibody at screening\n11. Participants must have an estimated glomerular filtration rate (eGFR) of 90 mL\u002Fmin\u002F1.73 m2 at screening\n12. Participants must have a negative urine test for drugs of abuse (see Appendix B), cotinine, and breath alcohol test at screening and Check-in (Day -1)\n13. Participants must be willing and able to abide by all study requirements and restrictions.\n\nExclusion Criteria:\n\n1. Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal (GI), 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 participant at an unacceptable risk as a participant in this study\n2. Evidence of systemic inflammation as measured by C-reactive protein above the upper limit of normal, as measured by the local lab\n3. History of malignancy (other than successfully treated basal cell or squamous cell skin cancer)\n4. History or presence of an abnormal electrocardiogram (ECG) that, in the opinion of the Investigator, is clinically significant\n5. 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) above the upper limit of normal at screening and\u002For Check-in is exclusionary. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator\n6. Has had an acute illness considered clinically significant by the Investigator within 30 days prior to screening\n7. History of alcoholism or drug abuse within 1 year prior to screening or excessive alcohol consumption defined as \\>14 standard drinks per week.\n8. Has used any product containing nicotine within 30 days prior to screening or intends to use any product containing nicotine during the study (exception of ≤ 5 cigarettes per week)\n9. Has had any immunizations (live vaccines) in the 4 weeks prior to screening; COVID-19 vaccination within 7 days of Day 1\n10. Has used any prescription (with the exception of hormonal contraceptives) or over-the counter medication (with the exception of acetaminophen), vitamins\u002Fherbal supplements within7 days prior to Day 1\n11. Has used any other study drug within 30 days or 5 half-lives of the drug (whichever is longer) prior to Day 112. Has lost or donated \\> 450 mL of whole blood or blood products within 7 days prior to screening\n\n13\\. Investigator has reason to believe that the participant may be unable to fulfill the protocol visit schedule or requirements 14. Has any finding that, in the view of the Investigator or Medical Monitor, would compromise the participant's safety requirements 15. Is employed by the Sponsor, the Contract Research Organization (CRO), or the study site (permanent, temporary contract worker, or designee responsible for the conduct of the study), or is a family member (spouse, parent, sibling, or child) of the Sponsor, CRO, or study site employee",true,"ALL","18 Years","65 Years",{"count":21,"type":22},36,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a Phase 1, open-label, multiple-dose study to evaluate the safety, tolerability, and PK of MGB after weekly subQ MGB administration in up to 36 healthy volunteers at 1 site in Australia.",[28],"Healthy Volunteers","NOT_YET_RECRUITING","2026-02-02",{"date":32,"type":33},"2026-02-04","ACTUAL",{"date":35,"type":22},"2026-01-29",{"date":37,"type":22},"2026-06-10",{"name":39,"class":40},"Ashvattha Therapeutics, Inc.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":23,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100469654","phase-1-safety-pk-and-biodistribution-of-18f-op-801-in-patients-with-als-ad-ms-pd-and-healthy-volunteers-100469654","NCT05395624","Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers","A Phase 1\u002F2 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","Inclusion Criteria:\n\n1. 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.\n2. Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and\u002For 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.\n3. 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:\n\n   1. Male subjects: condoms or surgical sterilization of subject at least 26 weeks before the Screening Visit (i.e., vasectomy).\n   2. Female subjects:\n\n      1. Surgical sterilization at least 26 weeks before the Screening Visit (includes hysterectomy or bilateral tubal ligation, bilateral oophorectomy, or salpingectomy);\n      2. Intrauterine device or diaphragm with spermicide for at least 12 weeks before the Screening Visit; or\n      3. Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks before the Screening Visit.\n4. If male, subjects must agree to abstain from sperm donation through 90 days after the Day 1 Visit.\n5. Female subjects may not be pregnant, lactating, or breastfeeding.\n6. Female subjects of childbearing potential must have negative result for pregnancy test at Screening and Check-in.\n7. Subjects must have an estimated glomerular filtration rate (eGFR) of \\>45 mL\u002Fmin\u002F1.73m2 at Screening.\n8. C-reactive protein level ≤10 mg\u002FdL.\n9. Subjects must be willing and able to abide by all study requirements and restrictions.\n\n   Inclusion Criteria Specific to ALS Subjects:\n10. Adult (Age 18 to 80, inclusive) at the Screening Visit\n11. Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by the modified El Escorial criteria.\n12. 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.\n13. For ALS subjects, medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.\n\n    Inclusion Criteria Specific to AD Subjects\n14. Adult (Age 40 to 80, inclusive) at the Screening Visit\n15. Clinical diagnosis of early stage dementia, Alzheimer type, plus positive Aβ and tau PET imaging, cerebrospinal fluid (CSF) and\u002For plasma biomarkers consistent with 2018 NIA-AA criteria\n16. MMSE score \\>20 at Screening\n17. AD medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.\n\n    Inclusion Criteria Specific to MS Subjects:\n18. Adult (Age 18 to 70, inclusive) at the Screening Visit\n19. MS medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.\n\n    Inclusion criteria specific to subjects with RRMS:\n20. Diagnosis of RRMS based on 2017 McDonald criteria\n21. If not newly diagnosed, subjects should have at least 1 documented relapse in the last 24 months.\n22. \"Active disease\" subjects should have at least 1 Gadolinium-enhancing (Gd+) T1-weighted brain or spinal cord lesion at Screening MRI.\n23. \"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.\n24. EDSS score between 2.0 and 5.5 inclusive at Screening\n\n    Inclusion criteria specific to subjects with progressive MS:\n25. Diagnosis of PPMS or SPMS based on 2017 McDonald criteria\n26. EDSS score between 3.0 and 6.5 inclusive at Screening\n27. No evidence of relapse in the prior 6 months\n28. Neurological exam and symptom stability for ≥30 days prior to Day 1\n29. Documented evidence of disability progression in the past 24 months not temporally related to a relapse\n\n    Inclusion Criteria Specific to PD Subjects:\n30. Adult (Age 55 to 80, inclusive) at the Screening Visit\n31. Diagnosis of definite, idiopathic Parkinson's disease according to UK Parkinson's Society Brain Bank diagnostic criteria\n32. PD medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor.\n\nOverall Exclusion Criteria - For All Subjects:\n\nSubjects meeting any of the following criteria will be excluded from this study:\n\n1. Body weight \\>120 kg\n2. 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\n3. History of recurrent kidney or liver malignancy\n4. Pacemaker or defibrillator or any non-removable metallic foreign objects in the body not compatible with MRI\n5. Inability to lie in a PET\u002FCT or PET\u002FMRI scanner for up to 90 minutes at a time\n6. 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\u002For 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.\n7. Resolved acute illness considered clinically significant by the Investigator within 10 days prior to Screening\n8. 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.\n9. Positive urine drug test, marijuana test or cotinine test at Screening or Check-In\n10. Any immunizations within the 28 days prior to screening\n11. Received any other investigational medicinal product within 30 days or 5 half-lives (whichever is longer) prior to Day 1\n12. Corticosteroid treatment (e.g., prednisone, solumedrol) within 30 days of Baseline\n13. 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\n14. Lost or donated \\>450 mL of whole blood or blood products within 30 days prior to Screening\n15. MRI exclusion criteria: findings that may interfere with interpretation of the PET imaging, including but not limited to significant cortical\u002Fsubcortical cerebrovascular disease, infectious disease, space-occupying lesions, hydrocephalus or other abnormalities associated with CNS disease not related to ALS, AD, MS or PD\n16. 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).\n17. Investigator has reason to believe that the subject may be unable to fulfill the protocol visit schedule or requirements\n18. Has any finding that, in the view of the Investigator and Medical Monitor, would compromise the subject's safety in the trial\n\n    Exclusion Criteria Specific to MS Subjects:\n19. 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)\n20. Diagnosis of progressive multifocal leukoencephalopathy (PML)\n\n    Exclusion Criteria Specific to PD Subjects:\n21. Secondary, atypical, or genetic parkinsonism\n\n    Exclusion Criteria Specific to HV Subjects:\n22. Clinically relevant finding on physical examination at Screening\n23. Family history of neurological disease that may confound interpretation of imaging results\n24. 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","80 Years",{"count":50,"type":22},65,[25,52],"PHASE2","This is a Phase 1\u002F2 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.",[55,56,57,58],"Amyotrophic Lateral Sclerosis (ALS)","Parkinson Disease (PD)","Alzheimer Disease (AD)","Multiple Sclerosis (MS)","RECRUITING","2025-04-30",{"date":62,"type":33},"2025-05-02",{"date":64,"type":33},"2023-02-02",{"date":66,"type":22},"2026-05-01",{"name":39,"class":40},3,""]