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Monoclonal Antibodies

CSX-1004 for Opioid Use Disorder

Phase 1
Recruiting
Led By Steven Hull, MD
Research Sponsored by Cessation Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 months
Awards & highlights

Study Summary

This trial is testing a new drug to investigate its safety, tolerability, and how it's absorbed in healthy adults.

Who is the study for?
Healthy adults aged 18-50, weighing 50-100 kg with a BMI of 18.0 to 32.0 can join this trial. It's not for those who use drugs or alcohol, have significant health issues, or smoke cigarettes daily.Check my eligibility
What is being tested?
The study tests the safety and how the body processes CSX-1004, a potential opioid overdose treatment given by IV. Participants will receive either CSX-1004 or a placebo in increasing doses.See study design
What are the potential side effects?
Since it's an early-phase trial for CSX-1004, specific side effects are being studied but may include typical IV infusion reactions like pain at the injection site, fever, chills, rash or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
12-Lead electrocardiogram
Clinical laboratory assessments
Infusion site examination
+3 more
Secondary outcome measures
AUCinf
AUClast
Cmax
+2 more
Other outcome measures
Immunogenicity

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CSX-1004Experimental Treatment1 Intervention
Single doses of CSX-1004 Injection
Group II: PlaceboPlacebo Group1 Intervention
Sterile saline for injection

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Cessation Therapeutics, Inc.Lead Sponsor
Dr. Vince Clinical ResearchOTHER
1 Previous Clinical Trials
32 Total Patients Enrolled
Steven Hull, MDPrincipal InvestigatorDr. Vince Clinical Research
1 Previous Clinical Trials
32 Total Patients Enrolled

Frequently Asked Questions

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

Is enrollment still available for individuals aged 45 and over in this clinical experiment?

"In order to meet the inclusion requirements of this medical trial, applicants must fall between 18 and 50 years old."

Answered by AI

Has CSX-1004 acquired governmental authorization to be marketed?

"The safety of CSX-1004 is estimated to be a 1 due to the lack of data from Phase 1 trials, where only limited information concerning efficacy and security has been gathered."

Answered by AI

Who meets the criteria for participation in this clinical experiment?

"Those aged between 18 and 50 who have experienced an opioid overdose are eligible to join this clinical trial. 32 individuals need to be recruited for the study."

Answered by AI

How many individuals are being incorporated into this clinical research?

"Affirmative. Clinicaltrials.gov confirms that this research study, which was first announced on August 1st 2023, is actively enrolling subjects. 32 people are being sought from a single medical centre for participation in the trial."

Answered by AI

Are there still openings to participate in this experiment?

"Affirmative. Data on clinicaltrials.gov indicates that this research is presently recruiting individuals for participation. The trial was initially launched on August 1st 2023 and was last modified 17 days later, with the aim of enrolling 32 patients from one particular medical centre."

Answered by AI

What is the goal of this medical research?

"Reported by the trial's sponsor, Cessation Therapeutics Inc., Clinical laboratory assessments will serve as the primary endpoint that is observed over a 5-month period. Additionally, secondary measurements of AUCinf (Area under the curve from time zero extrapolated to infinity), AUClast (Area under the curve from time zero to last measurable concentration) and Tmax (Time for maximum serum concentration) are being collected."

Answered by AI

Who else is applying?

What site did they apply to?
Dr. Vince Clinical Research
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacokinetics of CSX-1004
2023. "Safety, Tolerability, and Pharmacokinetics of CSX-1004". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005402.
~0 spots leftby May 2024
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