[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Metro International Biotech, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"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":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100578799","phase-1-phase-1a-single-ascending-dose-study-of-mib-725-in-healthy-adults-100578799",false,"NCT06815991","Phase 1a Single Ascending Dose Study of MIB-725 in Healthy Adults","A Phase 1, Single Ascending Dose Administration of MIB-725 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Community Dwelling Healthy Adults","Inclusion Criteria:\n\n1. Is a non-smoking healthy adult, 19 to 60 years of age, inclusive\n2. Has a body mass index (BMI) between 19 and 37.5 kg\u002Fm2, inclusive\n3. Is free from clinically significant medical problems as determined by the Investigator\n4. Is able and willing to provide written informed consent.\n5. Is able and willing to provide authorization for the use and disclosure of personal health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA).\n\nExclusion Criteria:\n\n1. Is a current cigarette smoker\n2. AST or ALT \\> 1.5 times the upper limit of normal\n3. Hematocrit \\\u003C 37% or \\> 51%\n4. Diagnosis of diabetes mellitus, as indicated by use of diabetes medication, hemoglobin A1C \\> 6.4% or fasting glucose ≥126 mg\u002FdL\n5. Serum creatinine \\> 2.0 mg\u002FdL\n6. Current use of barbiturates, benzodiazepines, opiates, amphetamine, cannabinoids and cocaine\n7. Known allergy to niacin or nicotinamide mononucleotide\n8. Unwilling to refrain from drinking alcohol during the duration of the study\n9. Use of any other dietary supplement during the course of the trial\n10. Use of anabolic steroids, rhGH, DHEA, androstenedione, or any other performance enhancing drug\n11. In the judgment of the study physician, the participant is unlikely to comply with the study protocol for any reason or it may not be safe to administer the study medication\n12. Has a history of myocardial infarction, stroke, or heart failure in the preceding 6 months.\n13. Has a history of cancer other than nonmelanotic skin cancer requiring treatment in the previous 2 years.\n14. Has other medical conditions which, in the opinion of the Principal Investigator, would jeopardize the safety of the study subject or impact the validity of the study results.\n\nIn addition, female participants must:\n\n1. Be postmenopausal as indicated by cessation of menstruation at least one year before screening\n2. Not be pregnant and not planning to become pregnant over the next 6 months\n\nProhibited medications and substances:\n\n1. Current use of barbiturates, benzodiazepines, opiates, amphetamine, cannabinoids and cocaine\n2. Use of any other dietary supplement during the course of the trial. Subjects who are using a supplement containing nicotinamide, niacin, nicotinamide mononucleotide, or nicotinamide riboside may be included if they agree to stop the supplement at least 2 weeks prior to day 0 and during the entire duration of the study.\n3. Initiation of a new prescription drug during the preceding 4 weeks or during the course of the study\n4. Use of anabolic steroids, rhGH, DHEA, androstenedione, or any other performance enhancing drug\n\n   \\-",true,"ALL","19 Years","60 Years",{"count":21,"type":22},32,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This is a single center, open label (i.e. participants and study staff will not be masked to the intervention) single ascending dose study to evaluate the safety, tolerability, pharmaokinetics and pharmacodynamics of MIB-725 in community dwelling, healthy adults. Up to 4 successive groups (cohorts) of 8 subjects each will be enrolled in this trial.\n\nThis study will determine the safety and tolerability of orally administered single ascending (increasing) doses (100, 200, 400, and 800 mg) of MIB-725 in healthy adults. The safety will be assessed by evaluating physical examination that includes an external eye examination, vital signs, adverse events, and changes in blood counts, EKG, urinalysis, coagulation measures, and blood chemistries, including but not limited to blood glucose, electrolytes, creatinine, liver function tests, uric acid, and creatine kinase.",[28],"Healthy Adults",[30,31],"Phase 1","NAD Booster","RECRUITING","2026-02-16",{"date":35,"type":36},"2026-02-19","ACTUAL",{"date":38,"type":36},"2025-02-11",{"date":40,"type":22},"2027-03",{"name":42,"class":43},"Metro International Biotech, LLC","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":16,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":23,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":44},"100583881","phase-1-tracing-the-metabolic-flux-of-orally-administered-nad-precursors-100583881","NCT06882096","Tracing the Metabolic Flux of Orally Administered NAD+ Precursors","Tracing the Metabolic Flux of Orally Administered NAD+ Precursors in Healthy Young and Older Adults","INCLUSION CRITERIA\n\nA participant may be enrolled if he\u002Fshe is:\n\n1. A healthy, community-living, man or a woman between 18 and 40 years, inclusive or 65 years or older\n2. Has a body mass index (BMI) between 19 and 35 kg\u002Fm2, inclusive\n3. Is free from clinically significant medical problems as determined by the Investigator\n4. Is capable of providing written informed consent.\n5. Is willing and able to provide authorization for the use and disclosure of personal health information in accordance with Health Insurance Portability and Accountability Act.\n\nEXCLUSION CRITERIA\n\nA subject may not be enrolled if s\u002Fhe:\n\n1. Has AST or ALT \\> 2 times the upper limit of normal\n2. Hematocrit \\\u003C 36% or \\> 51% for men, or \\\u003C 35% to \\> 48% for women\n3. Diagnosis of diabetes, using diabetes medications or an A1C \\> 6.4%\n4. Serum creatinine \\> 2.0 mg\u002FdL or eGFR \\\u003C60 mL\u002Fmin\n5. Prohibited medications and substances: use of anabolic steroids, rhGH, DHEA, androstenedione, or any performance enhancing drug; Current use of opiates, amphetamine, cannabinoids and cocaine\n6. Use of any dietary supplement. Subjects who are using a supplement containing NAM (or niacin or NMN or NR) may be included if they agree to stop supplement at least 2 weeks before randomization.\n7. For women only: Pregnant or planning to get pregnant over the next 6 months, or lactating\n8. Participation in an investigational trial within the past 3 months\n9. Other medical conditions which, in the opinion of the investigator, would jeopardize safety or impact the validity of the study results\n\nFor women only:\n\nFemale of childbearing age: Use of oral contraceptives is allowed provided the contraceptive regimen was initiated at least 3 months before randomization and the participant agrees not to change the regimen during the course of the study.\n\nExcluded Medications and Treatments\n\n1. The ingestion of the following is prohibited during 14 days prior to Day 0 and for the duration of the intervention period:\n\n   * Products that contain niacin, nicotinic acid, nicotinamide in any form, other than natural foods\n   * Herbal supplements\n2. Treatment with another investigational drug, investigational device, or approved therapy for investigational use within 3 month is prohibited.","18 Years",{"count":21,"type":22},[25],"We are doing this research to learn how healthy younger and older adults use two forms of vitamin B3-called nicotinamide mononucleotide (NMN) and nicotinamide (NAM)-to make NAD+. NAD+ is a natural substance that cells need for energy and other important processes. Our goal is to find out how these NAD precursors are absorbed and metabolized and how they raise NAD+ in different tissues.\n\nWho can join? Healthy adults men and women aged 18 to 40 (younger group) or 65 and older (older group) Participants with a body mass index ranging between 19 and 35 No major health issues like diabetes or severe kidney disease\n\nWhat will happen? Participants will take labeled or unlabeled NMN or NAM by mouth every day for 14 days.\n\nResearchers will collect blood, urine, and stool samples. Researchers also do a small muscle biopsy (under local numbing) twice to check how these NAD precursors raise NAD+ in muscle.\n\nWhy is this important? NAD+ levels may drop as people age, and this drop could affect overall health and energy in cells.\n\nA better understanding of how NMN and NAM are metabolized in the body to raise NAD+ levels in both younger and older adults may help us optimize dosing and strategies for raising NAD in older people.\n\nPossible benefits and risks:\n\nParticipants may not get any direct health benefit from this study; the main goal is to gather new knowledge.\n\nNMN and NAM appear safe in the doses used. A muscle biopsy may cause soreness or bruising.\n\nResearchers will monitor participants closely for any side effects throughout the study.",[28],"2025-05-05",{"date":59,"type":36},"2025-05-06",{"date":61,"type":36},"2025-04-28",{"date":63,"type":22},"2027-06",{"name":42,"class":43},""]