[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612286":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":68,"collaborators":32,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":32,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":32,"enrollmentInfo":80,"targetDuration":32,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":32,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"ChromaDex, Inc.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"50 mg Subcutaneous Niagen®Plus","EXPERIMENTAL","Participants receive 50 mg Niagen®Plus administered subcutaneously (under the skin) once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100.",[13],"Drug: Niagen®Plus",{"label":15,"type":10,"description":16,"interventionNames":17},"100 mg Subcutaneous Niagen®Plus","Participants receive 100 mg Niagen®Plus administered subcutaneously once daily for three consecutive days during in-clinic visits (Days 1-3). Participants then continue self-administered subcutaneous injections of the same dose three times per week (Monday, Wednesday, Friday) from Days 10-100.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"50 mg Intramuscular Niagen®Plus","Participants receive 50 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"100 mg Intramuscular Niagen®Plus","Participants receive 100 mg Niagen®Plus administered intramuscularly (into the deltoid muscle) once daily for three consecutive days during in-clinic visits (Days 1-3). No further at-home injections are performed; participants return for follow-up visits on Days 10, 40, and 100.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Niagen®Plus","Pharmaceutical-grade nicotinamide riboside chloride (NRCl), compounded for sterility and reconstituted in bacteriostatic water for injection. Administered by subcutaneous or intramuscular injection at 50 mg or 100 mg per dose. Participants receive three clinician-administered injections during clinic visits on Days 1-3, followed by at-home subcutaneous self-administration three times per week (Monday, Wednesday, Friday) from Days 10-100, depending on study arm.",[23,15,19,9],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Anne Russ, M.S.","CONTACT","13058482347","research@impacthealthteam.com",[40],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"BTT Medical Institute Aventura North","RECRUITING","Miami","Florida","33180","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-80.19366,25.77427,{"lat":52,"lon":51},[55,59,62,65],{"name":56,"role":36,"phone":57,"phoneExt":32,"email":58},"Robert Mogel","+1 (609) 915-9639","rmogel@bttcorp.com",{"name":60,"role":36,"phone":61,"phoneExt":32,"email":38},"Karolline Catoira","7867071444",{"name":63,"role":64,"phone":32,"phoneExt":32,"email":32},"Halland Chen, M.D.","PRINCIPAL_INVESTIGATOR",{"name":66,"role":67,"phone":32,"phoneExt":32,"email":32},"James Clement, J.D., L.L.M., Ph.D.","SUB_INVESTIGATOR",{"type":69,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100612286","phase-1-randomized-open-label-safety-study-of-subcutaneous-and-intramuscular-injections-of-niagen-plus-100612286",false,"NCT07251608","Randomized, Open-label, Safety Study of Subcutaneous and Intramuscular Injections of Niagen® Plus","Randomized, Open-Label, Safety Pilot Study of Multiple Subcutaneous and Intramuscular Injections of Niagen® Plus","Inclusion Criteria:\n\n* Generally healthy adults, aged 18+\n* Demonstrated baseline fatigue as determined by a below average score from the FAS (threshold prespecified in SAP).\n* NAD+ or NAD+ precursor injection naïve (including intravenous, intramuscular, subcutaneous, or other injection route) (i.e., 8 weeks abstinent)\n* Non-anemic\n* Willingness to adhere to lifestyle considerations and study procedures.\n* Ability to read English, and provide written informed consent.\n* Willingness to self-administer the study material, via subcutaneous injection for 90 days (days 10-100 of the study), and complete finger prick blood collections.\n\nExclusion Criteria:\n\n* One or more uncontrolled chronic illness including but not limited to diabetes, cardiovascular disease, liver, disease, kidney disease, or any form of cancer. An uncontrolled chronic illness, in this case, is defined as any changes to medication or other treatment modalities in the last 90 Days.\n* More than one chronic disease diagnosis under active treatment.\n* Any chronic disease, as determined by the primary investigator, that increases risk or confounds safety.\n* Any acute illness within 14 Days prior to Visit 1 (Day 1).\n* Cancer diagnosis within the last 5 years\n* Anemia (as defined by hemoglobin levels below 100 g\u002FL, and other blood measures)\n* Current pregnancy or lactation; unwilling to use effective contraception if of childbearing potential.\n* Use of any NAD+ supplement, NAD+ precursor, or vitamin B3 product, orally, nasally, by patch, or injection within the last 60 Days. NAD+ precursors and related compounds include niacin (NA), nicotinamide (NAM), nicotinamide riboside (NR), nicotinamide mononucleotide (NMN), NAD+, NADH, NAD+3, inositol hexanicotinate, apigenin; etc. The exception is the use of a daily oral multivitamin, that may contain vitamin B3 (niacin\u002Fnicotinamide). Such use will need to be documented.\n* Hypersensitivity or allergy to NR, niacin, other forms of vitamin B3\u002FNAD+ precursors, bacteriostatic water\n* Significant aversion to needles or finger pricks.\n* Participation in another clinical intervention study, 90 Days (or 5 half-lives of the intervention, whichever is longer) prior to Visit 1 (Day 1).\n* Any other condition rendering the participant unsuitable per investigator.\n* Excessive daily use of alcohol, defined as 4 or more drinks on one occasion, or illicit drug use which would prevent adherence to the protocol as determined by the investigator.",true,"ALL","18 Years",{"count":81,"type":82},40,"ESTIMATED","INTERVENTIONAL",[85],"PHASE1","The goal of this study is to learn about the safety of Niagen®Plus, an injectable form of nicotinamide riboside (NR), and to see how it affects levels of NAD+ in the blood. Niagen®Plus will be given either by subcutaneous (under the skin) or intramuscular (into the muscle) injection at two dose levels (50 mg or 100 mg).\n\nThe main questions this study aims to answer are:\n\nIs Niagen®Plus safe and well-tolerated when given by injection several times over 100 days?\n\nHow do NAD+ levels in blood change after repeated doses of Niagen®Plus?\n\nWhat are participants' and clinicians' experiences with the injections?\n\nResearchers will also look at changes in fatigue, sleep, quality of life, inflammation markers, mitochondrial efficiency, and perceived skin appearance.\n\nParticipants will:\n\nReceive three injections in clinic on Days 1-3, followed by a Day 10 follow-up visit\n\nSelf-inject Niagen®Plus at home three times per week from Days 10-100\n\nReturn to the clinic on Days 40 and 100 for safety and laboratory testing\n\nComplete short surveys about fatigue, sleep, and overall well-being throughout the study\n\nThe study will include 40 generally healthy adults and will last about 100 days per participant.",[88,89],"Healthy Volunteer","Fatigue","2025-11-19",{"date":92,"type":93},"2025-11-26","ACTUAL",{"date":95,"type":93},"2025-10-01",{"date":97,"type":82},"2026-02-15",{"name":5,"class":6},1]