Injectable Niagen®Plus given under the skin or into muscle at two dose levels

Randomized, Open-Label, Safety Pilot Study of Multiple Subcutaneous and Intramuscular Injections of Niagen® Plus

This trial tests whether injectable Niagen®Plus (50 mg or 100 mg), given under the skin or into muscle, is safe and raises blood NAD+ in generally healthy adults who report fatigue.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ChromaDex, Inc. (industry)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT07251608 on ClinicalTrials.gov

What this trial studies

This single-site, randomized, open-label, parallel 4-arm Phase 1 pilot trial gives participants three in-clinic injections on Days 1–3 (50 mg or 100 mg, subcutaneous or intramuscular), a safety follow-up on Day 10, then home self-administration of subcutaneous injections three times per week through Day 100 with clinic visits on Days 40 and 100. Primary endpoints are safety and tolerability measured by vital signs, comprehensive metabolic and hematologic panels, homocysteine, and adverse-event monitoring. Secondary endpoints track changes in whole-blood NAD+ using dried blood spots and clinician- and participant-reported injection experience, with exploratory measures of fatigue/energy, sleep, quality of life, inflammation markers, mitochondrial efficiency, oxidative stress, and perceived skin appearance. The target enrollment is about 40 generally healthy adults with baseline fatigue.

Who should consider this trial

Good fit: Adults 18 or older who are generally healthy, non-anemic, report baseline fatigue (below-average FAS score), are naïve to NAD+ or NAD+ precursor injections, and are willing to self-inject and attend scheduled clinic visits are eligible.

Not a fit: People with uncontrolled chronic illnesses, more than one chronic disease diagnosis, active cancer, or recent changes in chronic disease treatments are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the intervention could demonstrate a safe way to raise blood NAD+ levels and potentially improve energy or fatigue in some people.

How similar studies have performed: Oral nicotinamide riboside has raised NAD+ in prior studies with mixed clinical benefits, but injectable Niagen®Plus given subcutaneously or intramuscularly is largely novel and not well tested in humans.

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.

Where this trial is running

Miami, Florida

• BTT Medical Institute Aventura North — Miami, Florida, United States (RECRUITING)

Study contacts

• Study coordinator: Anne Russ, M.S.

Conditions: Healthy Volunteer, Fatigue