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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours

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

Do I qualify?Apply below to find out

Find a Location

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

2,470 Previous Clinical Trials

2,619,691 Total Patients Enrolled

Frequently Asked Questions

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

Do participants younger than 75 meet the criteria for this study?

"Participants seeking to enroll in this research study must be between the ages of 18 and 55 years old."

Answered by AI

Which specific criteria must individuals meet in order to be considered suitable candidates for enrollment in this medical study?

"Individuals aged between 18 and 55 with a diagnosed substance use disorder are eligible to participate in this research. A total of 40 participants will be selected for the clinical trial."

Answered by AI

Are prospective patients still eligible to participate in this ongoing medical study?

"Indeed, according to the information presented on clinicaltrials.gov, this current trial is actively seeking suitable participants. The initial posting of the clinical trial was made on February 7th, 2024 and its most recent update occurred on March 12th, 2024. This study aims to enroll a total of 40 patients from a single designated site."

Answered by AI

Has the FDA granted approval for CS-1103 Injection to be administered as a single dose?

"Based on the phase of this clinical trial, which is Phase 1 and involves limited safety and efficacy data, our team rates the safety of CS-1103 Single dose of CS-1103 Injection as a level 1."

Answered by AI

What is the current number of individuals participating in this clinical investigation?

"Affirmative. The details on clinicaltrials.gov highlight the ongoing patient recruitment for this particular clinical trial. This study was initially published on February 7, 2024, and last revised on March 12, 2024. The research seeks to enroll a total of 40 volunteers from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants

2024. "A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06316973.

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