New drug NRS 033 tested in healthy people for first time
NCT ID NCT05724797
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a single dose of the experimental drug NRS 033 in 24 healthy adults aged 18 to 55. The main goal was to check safety and how the drug moves through the body. No treatment was given for any disease, so this study does not offer any direct health benefit to participants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
-
Apr 2023
- Finished
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Dec 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.
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Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Frontage Clinical Research Center
Secaucus, New Jersey, 07094, United States
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