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CS-1103 Single dose of CS-1103 Injection for Substance Use Disorder

Phase 1
Recruiting
Research Sponsored by Clear Scientific, 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 48 hours
Awards & highlights

Study Summary

This trial will test how safe and well-tolerated a new drug, CS-1103, is when given in increasing doses through a vein to healthy volunteers.

Who is the study for?
This trial is for healthy individuals who are interested in helping to test the safety of a new drug, CS-1103. Participants should not currently have any substance use disorders or history of methamphetamine abuse or overdose.Check my eligibility
What is being tested?
The study is testing the safety and how well the body handles different doses of CS-1103 when given through an IV. It's compared with sterile saline (a harmless saltwater solution). The doses will increase step by step to find out what amount is safe.See study design
What are the potential side effects?
Since this is a Phase 1a trial primarily focused on safety, specific side effects are unknown at this stage but may include typical reactions to IV infusions such as discomfort at injection site, nausea, headache, or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with treatment-related adverse events (AEs) assessed by electrocardiograms (ECGs)
Number of participants with treatment-related adverse events (AEs) assessed by laboratory parameters
Number of participants with treatment-related adverse events (AEs) assessed by physical examinations
+1 more
Secondary outcome measures
Time course of CS-1103 blood and urine concentrations

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CS-1103 Single dose of CS-1103 InjectionExperimental Treatment1 Intervention
CS-1103 for injection
Group II: PlaceboPlacebo Group1 Intervention
Sterile saline for injection

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Clear Scientific, Inc.Lead Sponsor
National Institute on Drug Abuse (NIDA)NIH
2,492 Previous Clinical Trials
2,623,016 Total Patients Enrolled
~0 spots leftby Jul 2024
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