NCT07251608 Randomized, Open-label, Safety Study of Subcutaneous and Intramuscular Injections of Niagen® Plus
| NCT ID | NCT07251608 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ChromaDex, Inc. |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-02-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-10-01 with a primary completion date of 2026-02-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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). The main questions this study aims to answer are: Is Niagen®Plus safe and well-tolerated when given by injection several times over 100 days? How do NAD+ levels in blood change after repeated doses of Niagen®Plus? What are participants' and clinicians' experiences with the injections? Researchers will also look at changes in fatigue, sleep, quality of life, inflammation markers, mitochondrial efficiency, and perceived skin appearance. Participants will: Receive three injections in clinic on Days 1-3, followed by a Day 10 follow-up visit Self-inject Niagen®Plus at home three times per week from Days 10-100 Return to the clinic on Days 40 and 100 for safety and laboratory testing Complete short surveys about fatigue, sleep, and overall well-being throughout the study The study will include 40 generally healthy adults and will last about 100 days per participant.
Eligibility Criteria
Inclusion Criteria: * Generally healthy adults, aged 18+ * Demonstrated baseline fatigue as determined by a below average score from the FAS (threshold prespecified in SAP). * NAD+ or NAD+ precursor injection naïve (including intravenous, intramuscular, subcutaneous, or other injection route) (i.e., 8 weeks abstinent) * Non-anemic * Willingness to adhere to lifestyle considerations and study procedures. * Ability to read English, and provide written informed consent. * 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. Exclusion Criteria: * 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. * More than one chronic disease diagnosis under active treatment. * Any chronic disease, as determined by the primary investigator, that increases risk or confounds safety. * Any acute illness within 14 Days prior to Visit 1 (Day 1). * Cancer diagnosis within the last 5 years * Anemia (as defined by hemoglobin levels below 100 g/L, and other blood measures) * Current pregnancy or lactation; unwilling to use effective contraception if of childbearing potential. * 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/nicotinamide). Such use will need to be documented. * Hypersensitivity or allergy to NR, niacin, other forms of vitamin B3/NAD+ precursors, bacteriostatic water * Significant aversion to needles or finger pricks. * Participation in another clinical intervention study, 90 Days (or 5 half-lives of the intervention, whichever is longer) prior to Visit 1 (Day 1). * Any other condition rendering the participant unsuitable per investigator. * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07251608 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07251608 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07251608 currently recruiting?
Yes, NCT07251608 is actively recruiting participants. Contact the research team at research@impacthealthteam.com for enrollment information.
Where is the NCT07251608 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07251608 clinical trial?
NCT07251608 is sponsored by ChromaDex, Inc.. The trial plans to enroll 40 participants.