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NCT06721494PHASE2Recruiting

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

Clear Scientific, Inc.

Start Date

2/5/2026

Completion Date

9/11/2026

Summary

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).

Eligibility Criteria

Age Range: 18 years to 55 years

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.

Interventions

DRUG

Methamphetamine

DRUG

Sterile Saline

DRUG

CS-1103

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Conditions

Methamphetamine IntoxicationMethamphetamine DisordersMethamphetamine Abuse

Locations

California Clinical Trials Medical Group

Glendale, California 91206

United States