Healthy VolunteersPhase 1NCT05724797
Single Ascending Dose Study of NRS 033 in Healthy Volunteers
A Phase 1 study testing NRS-033 in people with Healthy Volunteers, run by Nirsum Labs at 1 site in United States.
Trial summary
This is a phase 1, first in human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult male and female subjects 18 to 55 years of age, inclusive. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NRS-033
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 4 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female ≥18 and ≤55 years of age at time of consent
- Body mass index ≥18.0 to ≤35.0 kg/m2
- Medically healthy based on the absence of clinically significant abnormal vital sign
- Females must have a negative serum pregnancy test at time of screening and negative urine pregnancy test upon admission; also, females of childbearing potential must agree to use a highly effective means of contraception from Screening until 9 months after receiving the study medication.
- Male subjects with female partners of childbearing potential must agree to use a male condom and will be advised of the benefit for a female partner to use a highly effective method of contraception
- Agree to stay within National Institute on Alcohol Abuse and Alcoholism (NIAAA) low risk drinking criteria. For women, low-risk drinking is no more than 3 drinks on any single day and no more than 7 drinks per week. For men, it is defined as no more than 4 drinks on any single day and no more than 14 drinks per week.
- Agree not to take opioid analgesics.
Who cannot join
- Clinically significant medical or psychiatric diagnosis (assessed on history, physical exam, ECG, and/or blood tests; includes significant history of cardiovascular, pulmonary, hepatic, gallbladder, or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease).
- Significant neuropsychiatric diagnosis (e.g., major depression, suicidal ideation, multiple sclerosis, dementia) as reported by the subject, or a past history of suicide attempt.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- History over last 30 days of consuming alcohol >3 drinks day per day or >7 drinks per week if female; if male >4 drinks per day or >14 drinks per week.
- Currently uses tobacco or nicotine containing products, including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum.
- Reported history of a significant traumatic injury, major surgery, or open biopsy within the 4 weeks prior to signing the informed consent form.
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- Subject reported history of any use of long-term use of opioids agonists or antagonists; e.g., methadone, oxycodone, hydrocodone, naltrexone, buprenorphine.
- Subject reported history of any medications to treat opioid use disorder (MOUD); e.g., methadone, naltrexone, buprenorphine, kratom.
- Subject reports anticipated need for opioid analgesia in the next 12 months (e.g., planned surgery).
- Subject reports history or presence of allergic or adverse response (including rash or anaphylaxis) to naloxone, naltrexone, nalmefene, morphinan opioid agonists, benzyl alcohol or sesame oil.
- Positive urine drug screen (UDS) for barbiturates, benzodiazepines, cocaine, methamphetamine, or opioids.
- Positive alcohol breath test.
- Received an investigational drug within the last 30 days or 5 half-lives of the drug, whichever is longer, prior to administration of study medication.
- Has taken exclusionary prohibited medications within the last 30 days or 5 half-lives of the drug, whichever is longer.
- Subjects with a history of syncope, or have a history of symptomatic hypotension or symptomatic hypoglycemia.
- Subjects who test positive for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HbsAg), or Hepatitis C virus (HCV) antibody.
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Research Center
Secaucus, New Jersey, 07094
About this study
Official title: A Phase 1, First in Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of NRS 033 in Healthy Volunteers
This is a phase 1, first in human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult male and female subjects 18 to 55 years of age, inclusive.
Read the detailed description
Subjects will provide written informed consent and undergo a screening visit within 28 days of receiving study drug. Eligible subjects must have a negative urine drug screen (UDS) and a negative naloxone challenge test at Screening and at the check-in visit (Day -1). Upon completion of screening, eligible subjects will be admitted to the clinical research unit (CRU) on Day -1 and remain confined in the CRU through completion of all scheduled procedures on Day 4 to allow for safety labs, pharmacokinetic (PK) blood draws, ECGs, injection site assessments, and adverse event monitoring.
Study medication dosing will occur in the morning on Day 1 and serial blood samples for plasma concentration determination for PK analysis will be taken during this time at pre-dose and 0.25, 0.50, 1, 1.5, 2, 4, 8, 10, 12, 24 (day 2), 48 (day 3), and 72 (day 4) hours post dose. Additional blood PK samples will be taken at follow-up visits. A Safety Review Committee (SRC) will review blinded, preliminary data from Cohort 1 to make recommendations regarding escalation to Cohorts 2 and 3.
- Conditions
- Healthy Volunteers
- Being tested
- NRS-033, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRS-033Drug
A single dose of NRS-033 will be administered
PlaceboDrug
A single dose of matching placebo will be administered
| Study group | Role | What they receive |
|---|---|---|
| NRS-033: Cohorts 1-3 | Experimental | Cohorts 1-3: 6 participants in each cohort will receive active drug (NRS-033) Receives: Drug: NRS-033 |
| Placebo: Cohorts 1-3 | Placebo comparator | Cohorts 1-3: 2 participants in each cohort will receive the matching placebo dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events (TEAEs)
Number of Participants with TEAEs
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Severity of TEAEs
Severity of TEAEs
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Serious Adverse Events (SAEs)
Number of Participants with SAEs
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Discontinuation Due to Adverse Events (AEs)
Number of Participants who discontinue the study due to AEs
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Pharmacokinetics: AUC0-last
Area under the plasma concentration-time curve (AUC) from time 0 to last measurable plasma concentration
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Pharmacokinetics: AUC0-infinity
Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC0-last + AUCt-inf
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Pharmacokinetics: AUC0-inf %extrapolation
Percentage of AUC0-inf due to extrapolation from Tlast to infinity
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Pharmacokinetics: Cmax
Maximum observed plasma concentration (Cmax)
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Pharmacokinetics: Tmax
Time of Cmax
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Pharmacokinetics: t1/2
Terminal half-life (t1/2)
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Pharmacokinetics: Kel (λz)
Apparent terminal rate-constant, calculated using linear regression on the terminal portion of the Log-concentration versus time curve
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Pharmacokinetics: Vz/F
Apparent volume of distribution (Vz/F)
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Pharmacokinetics: CL/F
Apparent clearance (CL/F)
Measured: From predose through end of study visit, assessed up to study completion, an average of 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start17 Apr 2023
- Primary completion4 Dec 2024
- Study completion4 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nirsum Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- N Shah, MD, Study director, Nirsum Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724797
- Sponsor's protocol ID
- NRS-033-102
- Other IDs
- UG3DA048234
- Status last verified
- Dec 2025
- First submitted
- 1 Feb 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First in Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of NRS 033 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05724797
- Acronym / sponsor ID
- NRS-033-102
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nirsum LabsIndustry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 4 Dec 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 13 Feb 2023 (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.
This is a phase 1, first in human, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study in healthy adult male and female subjects 18 to 55 years of age, inclusive.
Detailed description
Subjects will provide written informed consent and undergo a screening visit within 28 days of receiving study drug. Eligible subjects must have a negative urine drug screen (UDS) and a negative naloxone challenge test at Screening and at the check-in visit (Day -1). Upon completion of screening, eligible subjects will be admitted to the clinical research unit (CRU) on Day -1 and remain confined in the CRU through completion of all scheduled procedures on Day 4 to allow for safety labs, pharmacokinetic (PK) blood draws, ECGs, injection site assessments, and adverse event monitoring.
Study medication dosing will occur in the morning on Day 1 and serial blood samples for plasma concentration determination for PK analysis will be taken during this time at pre-dose and 0.25, 0.50, 1, 1.5, 2, 4, 8, 10, 12, 24 (day 2), 48 (day 3), and 72 (day 4) hours post dose. Additional blood PK samples will be taken at follow-up visits. A Safety Review Committee (SRC) will review blinded, preliminary data from Cohort 1 to make recommendations regarding escalation to Cohorts 2 and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NRS-033: Cohorts 1-3 | Experimental | Drug: NRS-033Cohorts 1-3: 6 participants in each cohort will receive active drug (NRS-033) |
| Placebo: Cohorts 1-3 | Placebo comparator | Drug: PlaceboCohorts 1-3: 2 participants in each cohort will receive the matching placebo dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female ≥18 and ≤55 years of age at time of consent
- Body mass index ≥18.0 to ≤35.0 kg/m2
- Medically healthy based on the absence of clinically significant abnormal vital sign
- Females must have a negative serum pregnancy test at time of screening and negative urine pregnancy test upon admission; also, females of childbearing potential must agree to use a highly effective means of contraception from Screening until 9 months after receiving the study medication.
- Male subjects with female partners of childbearing potential must agree to use a male condom and will be advised of the benefit for a female partner to use a highly effective method of contraception
Key exclusion criteria (16 listed)
- Clinically significant medical or psychiatric diagnosis (assessed on history, physical exam, ECG, and/or blood tests; includes significant history of cardiovascular, pulmonary, hepatic, gallbladder, or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, or active sexually transmitted disease).
- Significant neuropsychiatric diagnosis (e.g., major depression, suicidal ideation, multiple sclerosis, dementia) as reported by the subject, or a past history of suicide attempt.
- Females who are pregnant, lactating, or likely to become pregnant during the study.
- History over last 30 days of consuming alcohol >3 drinks day per day or >7 drinks per week if female; if male >4 drinks per day or >14 drinks per week.
- Currently uses tobacco or nicotine containing products, including but not limited to cigarettes, electronic cigarettes, pipes, cigars, chewing tobacco, nicotine patch or nicotine gum.
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 |
|---|---|---|
| NRS-033A single dose of NRS-033 will be administered | Drug | NRS-033: Cohorts 1-3 |
| PlaceboA single dose of matching placebo will be administered | Drug | Placebo: Cohorts 1-3 |
Primary outcome
Incidence of Treatment Emergent Adverse Events (TEAEs)
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Number of Participants with TEAEs
Severity of TEAEs
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Severity of TEAEs
Serious Adverse Events (SAEs)
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Number of Participants with SAEs
Discontinuation Due to Adverse Events (AEs)
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Number of Participants who discontinue the study due to AEs
Pharmacokinetics: AUC0-last
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Area under the plasma concentration-time curve (AUC) from time 0 to last measurable plasma concentration
Pharmacokinetics: AUC0-infinity
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC0-last + AUCt-inf
Pharmacokinetics: AUC0-inf %extrapolation
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Percentage of AUC0-inf due to extrapolation from Tlast to infinity
Pharmacokinetics: Cmax
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Maximum observed plasma concentration (Cmax)
Pharmacokinetics: Tmax
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Time of Cmax
Pharmacokinetics: t1/2
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Terminal half-life (t1/2)
Pharmacokinetics: Kel (λz)
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Apparent terminal rate-constant, calculated using linear regression on the terminal portion of the Log-concentration versus time curve
Pharmacokinetics: Vz/F
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Apparent volume of distribution (Vz/F)
Pharmacokinetics: CL/F
Time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months
Apparent clearance (CL/F)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
N Shah, MD study director
Nirsum Labs
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 NRS-033 in people with Healthy Volunteers, run by Nirsum Labs 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 16 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: finished, as of the sponsor's last update on 8 Dec 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (TEAEs) (time frame: From predose through end of study visit, assessed up to study completion, an average of 15 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Dec 2025.