Clinical Trials in the USA / NCT06721494
Recruiting
Phase 2
A Single-Dose Study to Evaluate Safety and Efficacy of CS-1103 in Participants Receiving a Single Dose of Methamphetamine
NCT06721494 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Methamphetamine IntoxicationMethamphetamine DisordersMethamphetamine Abuse
Investigational drug(s) / intervention(s)
Methamphetamine: Methamphetamine HCl for intravenous administration
Sterile Saline: Sterile Saline for intravenous administration
CS-1103: CS-1103 for intravenous administration
Study 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
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.
Primary outcome measure(s)
- Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations — 3 days plus follow-up on Day 10
Physical examinations - Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs) — 3 days plus follow-up on Day 10
Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted. - Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs — 3 days plus follow-up on Day 10
Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature - Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters — 3 days plus follow-up on Day 10
Clinical chemistry, hematology, coagulation, and urinalysis - Time course and magnitude of urine excretion of methamphetamine — 48 hours
Measurement of concentration of methamphetamine in urine
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| California Clinical Trials Medical Group | Glendale | California | Recruiting |
More Clear Scientific, Inc. trials in the USA
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06721494 on ClinicalTrials.gov ↗ ← All trials in the USA