What side effects are associated with this type of intervention?

In clinical trials involving new drugs or biologics, common side effects observed in healthy subjects include local injection site reactions (such as erythema, pain, or bruising), mild hypersensitivity reactions (such as rash, pruritus, and urticaria), and gastrointestinal symptoms (such as diarrhea and nausea). Other potential side effects may include transient fatigue, headache, and mild neurocognitive symptoms. Serious adverse effects are uncommon but can include severe allergic reactions and, rarely, organ-specific toxicities.

What prior FDA approvals exist?

FDA approvals for treatments in healthy subjects typically occur in the context of phase 1 clinical trials, which are designed to assess the safety, tolerability, and pharmacokinetics of new drugs or biologics. These trials often involve healthy volunteers to establish a baseline understanding of how the drug behaves in the human body. Examples of such studies include single ascending dose (SAD) studies, where increasing doses of a drug are administered to different groups of healthy subjects to determine the maximum tolerated dose and identify any potential side effects. While specific drugs or biologics from these trials are not always disclosed until later phases, the primary focus remains on ensuring the initial safety and pharmacokinetic profile before proceeding to patient populations.

What other types of research exist?

Promising novel alternatives for the assessment of new drugs or biologics in healthy subjects include the use of advanced pharmacokinetic modeling techniques, such as physiologically based pharmacokinetic (PBPK) models, and the integration of artificial intelligence (AI) and machine learning (ML) to predict drug interactions and optimize dosing regimens. Additionally, the development of non-invasive biomarkers and imaging techniques for real-time monitoring of drug effects and the use of microdosing studies to gather early pharmacokinetic data with minimal risk are also noteworthy advancements.

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Unknown

NRS-033 for Healthy Volunteers

Phase 1

Waitlist Available

Research Sponsored by Nirsum Labs

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female ≥18 and ≤55 years of age at time of consent

Agree not to take opioid analgesics.

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from predose through end of study visit, assessed up to study completion, an average of 15 months

Summary

This trial tests a new drug in healthy adults aged 18 to 55. Researchers will observe how the drug works and monitor for any reactions. Participants will stay at a research center for a short period for close monitoring.

Who is the study for?

Healthy adults, aged 18-55, can join this trial. Men must use condoms and women need a negative pregnancy test and agree to contraception. Participants should drink alcohol within low-risk limits, not take opioids or certain other drugs, have no significant medical/psychiatric issues or recent surgeries/injuries.

What is being tested?

The study is testing NRS-033 in healthy volunteers compared to a placebo. It's the first time humans will receive it (Phase 1), with increasing doses given once to see how safe it is and how the body reacts over time.

What are the potential side effects?

Since this is a first-in-human study for NRS-033, specific side effects are unknown but may include typical drug trial reactions such as headaches, nausea, fatigue or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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I agree not to take any opioid painkillers.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any major health or mental health issues.

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I have a significant mental health condition or a history of suicide attempts.

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I am not pregnant, breastfeeding, or planning to become pregnant during the study.

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I drink less than the specified alcohol limits.

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I have used opioid medications for a long time.

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I have taken medication for opioid addiction, like methadone or buprenorphine.

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I am allergic to certain opioid antagonists or ingredients like benzyl alcohol or sesame oil.

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I have a history of fainting, low blood pressure, or low blood sugar.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from predose through end of study visit, assessed up to study completion, an average of 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from predose through end of study visit, assessed up to study completion, an average of 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from predose through end of study visit, assessed up to study completion, an average of 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Discontinuation Due to Adverse Events (AEs)

Incidence of Treatment Emergent Adverse Events (TEAEs)

Pharmacokinetics: AUC0-inf %extrapolation

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: NRS-033: Cohorts 1-3Experimental Treatment1 Intervention

Cohorts 1-3: 6 participants in each cohort will receive active drug (NRS-033)

Group II: Placebo: Cohorts 1-3Placebo Group1 Intervention

Cohorts 1-3: 2 participants in each cohort will receive the matching placebo dose

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

In early-phase clinical trials, such as single ascending dose studies, the primary focus is on understanding the pharmacokinetics and pharmacodynamics of new drugs or biologics. Pharmacokinetics involves studying how the drug is absorbed, distributed, metabolized, and excreted in the body, while pharmacodynamics examines the drug's biological effects and mechanisms of action. These studies are crucial for determining the safety, tolerability, and optimal dosing of the drug in healthy subjects, which helps to ensure that the drug can be safely and effectively used in future trials involving patients with specific medical conditions.

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