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

Major Inclusion Criteria:

• Healthy participants aged 18 to 55 years, inclusive;
• Meets DSM-5 criteria for methamphetamine use disorder;
• Not seeking treatment for methamphetamine use disorder;
• Primary route of methamphetamine self-administration must be intravenous or smoking;
• Able to abstain from methamphetamine without experiencing severe withdrawal;
• A body mass index between 18 to 30 kg/m2, inclusive and a minimum body weight of 56 kg;
• Females must not be lactating and must have a negative pregnancy test during screening and admission.

Major Exclusion Criteria:

• Estimated glomerular filtration rate <60 mL/min/1.73 m2;
• History of cardiovascular disease;
• Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines;
• History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.