Randomized, Open-label, Safety Study of Subcutaneous and Intramuscular Injections of Niagen® Plus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChromaDex, Inc.
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Niagen®Plus
DrugPharmaceutical-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.
Treatment groups
40 Participants
are divided into 4 treatment groupsGroup A: 50 mg Subcutaneous Niagen®PlusExperimental treatment 1 intervention
Group B: 100 mg Subcutaneous Niagen®PlusExperimental treatment 1 intervention
Group C: 50 mg Intramuscular Niagen®PlusExperimental treatment 1 intervention
Group D: 100 mg Intramuscular Niagen®PlusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events
The incidence and severity of treatment-associated moderate and severe adverse events (AEs) will be assessed.
Time frame
From Day 1 (first injection) through Day 100 (final visit)2
Blood Pressure
Blood pressure, systolic and diastolic, will be measured
Time frame
Immediately before the first intervention, and through the 100th day of the study.3
Heart Rate
Heart rate will be measured.
Time frame
Immediately before the intervention and through the 100th day of the study (final visit).4
Pulse Rate
Pulse rate will be measured.
Time frame
Immediately before and through the 100th day of the study (final visit).Secondary outcomes
1
Change in whole-blood NAD⁺ concentrations
Quantitative change in whole-blood NAD⁺ levels measured by dried blood spot (DBS) assay at baseline and follow-up visits to characterize pharmacodynamic response to Niagen®Plus administration.
Time frame
Baseline (Day 1) through Day 1002
Participant- and clinician-reported injection-site experience
Numeric rating scale (0-10) and clinician assessments of pain, erythema, swelling, and induration to characterize tolerability of subcutaneous versus intramuscular administration.
Time frame
Immediately post-injection through 180 minutes after dosing (Days 1-3)Sponsors and contacts
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Source ClinicalTrials.gov