Single Ascending Dose Study of NRS 033 in Healthy Volunteers

• Status: Not yet recruiting
• Trial end date: 2023-11-26
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Nirsum Labs
• Collaborator: National Institute on Drug Abuse (NIDA)

Criteria

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 elaidate, 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.