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

NCT07251608 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IH-NP-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer; Fatigue

Outcome Measures

Primary Outcomes (10)

• Incidence and severity of adverse events

  The incidence and severity of treatment-associated moderate and severe adverse events (AEs) will be assessed.

  From Day 1 (first injection) through Day 100 (final visit)

• Blood Pressure

  Blood pressure, systolic and diastolic, will be measured

  Immediately before the first intervention, and through the 100th day of the study.

• Heart Rate

  Heart rate will be measured.

  Immediately before the intervention and through the 100th day of the study (final visit).

• Pulse Rate

  Pulse rate will be measured.

  Immediately before and through the 100th day of the study (final visit).

• Respiratory Rate

  Respiratory rate will be measured.

  Immediately before and through the 100th day of the study (final visit).

• Blood Oxygen

  Blood oxygen level will be measured.

  Immediately before and through the 100th day of the study (final visit).

• Complete Blood Count

  A complete blood count with differential will be evaluated through whole blood samples

  Immediately before and through the 100th day of the study (final visit).

• Comprehensive Metabolic Panel

  Comprehensive metabolic panel will be evaluated through whole blood samples

  Immediately before and through the 100th day of the study (final visit).

• Homocysteine

  Homocysteine will be measured from venous blood samples as part of the primary safety laboratory panel. Levels will be analyzed as absolute values and change-from-baseline to evaluate any clinically significant elevations or shifts associated with repeat dosing of Niagen®Plus.

  Immediately before and through the 100th day of the study (final visit).

• High-Sensitivity C-Reactive Protein (hs-CRP)

  High-sensitivity C-reactive protein will be assessed from venous blood samples as part of the primary safety laboratory panel. hs-CRP is a sensitive biomarker of systemic inflammation and may signal acute or sub-acute inflammatory responses to repeated Niagen®Plus dosing. Levels will be analyzed as absolute values and change-from-baseline to identify any clinically meaningful elevations or trends. Data will be summarized descriptively by dose and route of administration to support safety evaluation.

  Immediately before and through the 100th day of the study (final visit).

Secondary Outcomes (2)

• Change in whole-blood NAD⁺ concentrations

  Baseline (Day 1) through Day 100

• Participant- and clinician-reported injection-site experience

  Immediately post-injection through 180 minutes after dosing (Days 1-3)

Study Arms (4)

50 mg Subcutaneous Niagen®Plus

EXPERIMENTAL

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.

Drug: Niagen®Plus

100 mg Subcutaneous Niagen®Plus

EXPERIMENTAL

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.

Drug: Niagen®Plus

50 mg Intramuscular Niagen®Plus

EXPERIMENTAL

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.

Drug: Niagen®Plus

100 mg Intramuscular Niagen®Plus

EXPERIMENTAL

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.

Drug: Niagen®Plus

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.

100 mg Intramuscular Niagen®Plus; 100 mg Subcutaneous Niagen®Plus; 50 mg Intramuscular Niagen®Plus; 50 mg Subcutaneous Niagen®Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ChromaDex, Inc.: lead

Study Sites (1)

BTT Medical Institute Aventura North

Miami, Florida, 33180, United States

RECRUITING

Related Publications (1)

• Conze D, Brenner C, Kruger CL. Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults. Sci Rep. 2019 Jul 5;9(1):9772. doi: 10.1038/s41598-019-46120-z.

  PMID: 31278280 BACKGROUND

Related Links

• Commercial listing of the same compounded product (Niagen Plus injection) that is being used as the investigational product.
• Laboratory assay measuring mitochondrial efficiency from dried blood spots, used as an exploratory endpoint in the study.
• The current study's previous clinical trial with unpublished results.

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Anne Russ, M.S.

CONTACT

13058482347; research@impacthealthteam.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are randomized 1:1:1:1 into four parallel arms receiving Niagen®Plus by either subcutaneous or intramuscular injection at two dose levels (50 mg or 100 mg).

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 26, 2025
• Study Start: October 1, 2025
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)