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Unknown

NRS-033 for Healthy Volunteers

Phase 1
Recruiting
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from predose through end of study visit, assessed up to 6 months
Awards & highlights

Study Summary

This trial tests a new drug in healthy people to see if it is safe and effective.

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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 55 years old.
Select...
I agree not to take any opioid painkillers.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from predose through end of study visit, assessed up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from predose through end of study visit, assessed up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Nirsum LabsLead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,469 Previous Clinical Trials
2,619,385 Total Patients Enrolled
N Shah, MDStudy DirectorNirsum Labs

Media Library

NRS-033 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05724797 — Phase 1
Healthy Subjects Research Study Groups: Placebo: Cohorts 1-3, NRS-033: Cohorts 1-3
Healthy Subjects Clinical Trial 2023: NRS-033 Highlights & Side Effects. Trial Name: NCT05724797 — Phase 1
NRS-033 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05724797 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05724797 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project encompass those above the age of 45?

"In accordance with the criteria for participation, the lower age limit is 18 and upper age limit for enrolment in this trial is 55."

Answered by AI

Are there vacancies for participants in this research project?

"According to clinicaltrials.gov, the posting for this trial is no longer active as of February 10th 2023 and has ceased recruitment efforts. Nevertheless, there are 824 other medical studies looking for participants currently."

Answered by AI

Has the FDA endorsed NRS-033: Cohorts 1-3?

"Our team's review gave NRS-033: Cohorts 1-3 a score of 1 due to the limited safety and efficacy data available from this Phase 1 clinical trial."

Answered by AI

Am I eligible to enroll in this investigation?

"This clinical study requires 24 participants between 18 and 55 who are in good health. Other prerequisites include a body mass index of 18-35 kg/m2, no clinically significant abnormal vital signs on screening, negative pregnancy tests for female subjects, agreement to not take opioid analgesics, and adherence to NIAAA's low risk drinking criteria (3 drinks per day or 7 drinks per week for women; 4 drinks per day or 14 drinks per week for men). Additionally, male patients with female partners of childbearing potential must use condoms while the female partner uses highly effective contraception methods."

Answered by AI

Who else is applying?

What state do they live in?
New York
Florida
New Jersey
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What site did they apply to?
Frontage Clinical Research Center
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

Will travel be compensated?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

I am interested in paid clinical trials. This sounds interesting but a little vague.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Single Ascending Dose Study of NRS 033 in Healthy Volunteers
2023. "Single Ascending Dose Study of NRS 033 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05724797.
~3 spots leftby Jun 2024
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