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A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine

RecruitingPhase 2Ages 18 Years - 55 YearsAllClear Scientific, Inc.
NCT06721494 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of four single, increasing doses of CS-1103, given by intravenous (IV) infusion in otherwise healthy, non-treatment seeking participants with methamphetamine use disorder in the presence of a clinically relevant dose of methamphetamine HCl (30 mg IV).

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📋 Eligibility rules (as published)
Major Inclusion Criteria: 1. Healthy participants aged 18 to 55 years, inclusive; 2. Meets DSM-5 criteria for methamphetamine use disorder; 3. Not seeking treatment for methamphetamine use disorder; 4. Primary route of methamphetamine self-administration must be intravenous or smoking; 5. Able to abstain from methamphetamine without experiencing severe withdrawal; 6. A body mass index between 18 to 30 kg/m2, inclusive and a minimum body weight of 56 kg; 7. Females must not be lactating and must have a negative pregnancy test during screening and admission. Major Exclusion Criteria: 1. Estimated glomerular filtration rate \<60 mL/min/1.73 m2; 2. History of cardiovascular disease; 3. Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines; 4. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
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What it tests

  • Methamphetamine
  • Sterile Saline
  • CS-1103
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Where

1 site
California Clinical Trials Medical Group
Glendale, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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