A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
A Phase 2 Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants With Methamphetamine Use Disorder Not Seeking Treatment Receiving a Single Dose of Methamphetamine
Clear Scientific, Inc.
40 participants
Feb 5, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 50 kg;
- Females must not be lactating and must have a negative pregnancy test during screening and admission.
Exclusion Criteria4
- 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.
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Interventions
Methamphetamine HCl for intravenous administration
Sterile Saline for intravenous administration
CS-1103 for intravenous administration
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06721494