Healthy VolunteerPhase 1NCT07251608
Randomized, Open-label, Safety Study of Subcutaneous and Intramuscular Injections of Niagen® Plus
A Phase 1 study testing Niagen®Plus in people with Healthy Volunteer and Fatigue, run by ChromaDex, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Fatigue
- What is being tested?
- Niagen®Plus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 15 Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
BTT Medical Institute Aventura North
Miami, Florida, 33180
Robert Mogel, +1 (609) 915-9639, rmogel@bttcorp.com
Karolline Catoira, 7867071444, research@impacthealthteam.com
About this study
Official title: Randomized, Open-Label, Safety Pilot Study of Multiple Subcutaneous and Intramuscular Injections of Niagen® Plus
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:
Read more
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.
Read the detailed description
This is a single-site, prospective, randomized, open-label, parallel 4-arm pilot trial designed to evaluate the safety and pharmacodynamic effects of Niagen®Plus (nicotinamide riboside chloride, NRCl) when administered by injection. The study includes two phases over approximately 100 days per participant.
In Phase 1, participants receive three consecutive daily injections of Niagen®Plus (50 mg or 100 mg; subcutaneous or intramuscular) administered in clinic on Days 1-3, followed by a Day 10 follow-up visit for safety evaluation and laboratory testing. In Phase 2, participants continue self-administration of subcutaneous Niagen®Plus at home three times per week (Monday, Wednesday, Friday) through Day 100, returning to the clinic on Days 40 and 100 for repeat safety assessments, sample collection, and exploratory analyses.
Primary endpoints assess safety and tolerability through vital signs, comprehensive metabolic and hematologic panels (CMP, CBC, homocysteine), and adverse-event monitoring. Secondary endpoints include changes in whole-blood NAD⁺ concentrations measured by dried-blood-spot analysis and clinician- and participant-reported injection experience. Exploratory endpoints include fatigue, energy, sleep, and quality-of-life assessments; plasma biomarkers of inflammation (C-reactive protein); phenotypic age calculation; oxidative stress testing (in urine); mitochondrial efficiency testing; and subjective evaluations of skin appearance.
The target enrollment is 40 generally healthy adults (10 per arm). The study is not powered for hypothesis testing but will inform the design of subsequent placebo-controlled trials by characterizing safety profiles, pharmacokinetic trends, and feasibility of at-home administration.
- Conditions
- Healthy Volunteer, Fatigue
- Being tested
- Niagen®Plus
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niagen®PlusDrug
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Niagen®Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
The incidence and severity of treatment-associated moderate and severe adverse events (AEs) will be assessed.
Measured: From Day 1 (first injection) through Day 100 (final visit)
Blood Pressure
Blood pressure, systolic and diastolic, will be measured
Measured: Immediately before the first intervention, and through the 100th day of the study.
Heart Rate
Heart rate will be measured.
Measured: Immediately before the intervention and through the 100th day of the study (final visit).
Pulse Rate
Pulse rate will be measured.
Measured: Immediately before and through the 100th day of the study (final visit).
Respiratory Rate
Respiratory rate will be measured.
Measured: Immediately before and through the 100th day of the study (final visit).
Blood Oxygen
Blood oxygen level will be measured.
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Immediately before and through the 100th day of the study (final visit).
Secondary outcomes (2)
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.
Measured: Baseline (Day 1) through Day 100
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.
Measured: Immediately post-injection through 180 minutes after dosing (Days 1-3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Oct 2025
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ChromaDex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251608
- Sponsor's protocol ID
- IH-NP-101
- Status last verified
- Nov 2025
- First submitted
- 3 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. De-identified aggregate data and summary results will be shared with the sponsor and may be included in publications or presented at scientific meetings.
Publications
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.
PubMed 31278280
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, Safety Pilot Study of Multiple Subcutaneous and Intramuscular Injections of Niagen® Plus
- ClinicalTrials.gov ID
- NCT07251608
- Acronym / sponsor ID
- IH-NP-101
- Conditions
- Healthy Volunteer, Fatigue
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- ChromaDex, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single-site, prospective, randomized, open-label, parallel 4-arm pilot trial designed to evaluate the safety and pharmacodynamic effects of Niagen®Plus (nicotinamide riboside chloride, NRCl) when administered by injection. The study includes two phases over approximately 100 days per participant.
In Phase 1, participants receive three consecutive daily injections of Niagen®Plus (50 mg or 100 mg; subcutaneous or intramuscular) administered in clinic on Days 1-3, followed by a Day 10 follow-up visit for safety evaluation and laboratory testing. In Phase 2, participants continue self-administration of subcutaneous Niagen®Plus at home three times per week (Monday, Wednesday, Friday) through Day 100, returning to the clinic on Days 40 and 100 for repeat safety assessments, sample collection, and exploratory analyses.
Primary endpoints assess safety and tolerability through vital signs, comprehensive metabolic and hematologic panels (CMP, CBC, homocysteine), and adverse-event monitoring. Secondary endpoints include changes in whole-blood NAD⁺ concentrations measured by dried-blood-spot analysis and clinician- and participant-reported injection experience. Exploratory endpoints include fatigue, energy, sleep, and quality-of-life assessments; plasma biomarkers of inflammation (C-reactive protein); phenotypic age calculation; oxidative stress testing (in urine); mitochondrial efficiency testing; and subjective evaluations of skin appearance.
The target enrollment is 40 generally healthy adults (10 per arm). The study is not powered for hypothesis testing but will inform the design of subsequent placebo-controlled trials by characterizing safety profiles, pharmacokinetic trends, and feasibility of at-home administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 50 mg Subcutaneous Niagen®Plus | Experimental | Drug: Niagen®PlusParticipants 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. |
| 100 mg Subcutaneous Niagen®Plus | Experimental | Drug: Niagen®PlusParticipants 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. |
| 50 mg Intramuscular Niagen®Plus | Experimental | Drug: Niagen®PlusParticipants 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. |
| 100 mg Intramuscular Niagen®Plus | Experimental | Drug: Niagen®PlusParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niagen®PlusPharmaceutical-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. | Drug | 100 mg Intramuscular Niagen®Plus, 100 mg Subcutaneous Niagen®Plus, 50 mg Intramuscular Niagen®Plus, 50 mg Subcutaneous Niagen®Plus |
Primary outcome
Incidence and severity of adverse events
Time frame: From Day 1 (first injection) through Day 100 (final visit)
The incidence and severity of treatment-associated moderate and severe adverse events (AEs) will be assessed.
Blood Pressure
Time frame: Immediately before the first intervention, and through the 100th day of the study.
Blood pressure, systolic and diastolic, will be measured
Heart Rate
Time frame: Immediately before the intervention and through the 100th day of the study (final visit).
Heart rate will be measured.
Pulse Rate
Time frame: Immediately before and through the 100th day of the study (final visit).
Pulse rate will be measured.
Respiratory Rate
Time frame: Immediately before and through the 100th day of the study (final visit).
Respiratory rate will be measured.
Blood Oxygen
Time frame: Immediately before and through the 100th day of the study (final visit).
Blood oxygen level will be measured.
Complete Blood Count
Time frame: Immediately before and through the 100th day of the study (final visit).
A complete blood count with differential will be evaluated through whole blood samples
Comprehensive Metabolic Panel
Time frame: Immediately before and through the 100th day of the study (final visit).
Comprehensive metabolic panel will be evaluated through whole blood samples
Homocysteine
Time frame: Immediately before and through the 100th day of the study (final visit).
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.
High-Sensitivity C-Reactive Protein (hs-CRP)
Time frame: Immediately before and through the 100th day of the study (final visit).
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.
2 secondary outcomes
Change in whole-blood NAD⁺ concentrations
Time frame: Baseline (Day 1) through Day 100
Participant- and clinician-reported injection-site experience
Time frame: Immediately post-injection through 180 minutes after dosing (Days 1-3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 31278280Conze 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.
- Commercial listing of the same compounded product (Niagen Plus injection) that is being used as the investigational product.Link provided by the sponsor.
- Laboratory assay measuring mitochondrial efficiency from dried blood spots, used as an exploratory endpoint in the study.Link provided by the sponsor.
- The current study's previous clinical trial with unpublished results.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. De-identified aggregate data and summary results will be shared with the sponsor and may be included in publications or presented at scientific meetings.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Niagen®Plus in people with Healthy Volunteer and Fatigue, run by ChromaDex, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Russ, M.S. (13058482347, research@impacthealthteam.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events (time frame: From Day 1 (first injection) through Day 100 (final visit)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07251608, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.