Randomized, Open-label, Safety Study of Subcutaneous and Intramuscular Injections of Niagen® Plus

Part of paid clinical trials in Miami, Florida.

Sponsor
ChromaDex, Inc.
Study ID
NCT07251608
Phase
PHASE1
Status
Recruiting
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Conditions

  • Fatigue
  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Niagen®Plus — DRUG
    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.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Nov 2025
Primary completion
Feb 15, 2026
Completion
Feb 15, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 50 mg Subcutaneous Niagen®Plus
    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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

Incidence and severity of adverse events [ Time Frame: From Day 1 (first injection) through Day 100 (final visit) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
BTT Medical Institute Aventura NorthMiamiFlorida33180
Robert Mogel
[email protected]
+1 (609) 915-9639
Karolline Catoira
[email protected]
7867071444
Halland Chen, M.D. (PRINCIPAL_INVESTIGATOR)
James Clement, J.D., L.L.M., Ph.D. (SUB_INVESTIGATOR)

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By research site
BTT Medical Institute Aventura North· Miami, FL

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