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
Conditions
Methamphetamine IntoxicationMethamphetamine DisordersMethamphetamine Abuse
Locations
California Clinical Trials Medical Group
Glendale, California 91206
United States