Phase 2 Study to Assess Safety and Effectiveness of CS-1103 in Adults with Methamphetamine Use Disorder Receiving a Single Methamphetamine Dose

What this Trial Is About

Researchers are evaluating the safety, effectiveness, and how the body processes different single rising doses of CS-1103 when given by intravenous infusion to otherwise healthy adults with methamphetamine use disorder who are not seeking treatment. Participants receive a clinically relevant dose of methamphetamine hydrochloride 30 mg IV alongside the study drug or placebo. This phase 2 trial focuses on methamphetamine intoxication and related disorders in adults aged 18 to 55 years. Participants are randomly assigned to receive methamphetamine HCl 30 mg followed either by a placebo saline or one of four escalating doses of CS-1103 via intravenous infusion. The study uses a sequential model to assess each doses safety and pharmacokinetics. The treatment involves a single administration of methamphetamine followed closely by the study drug or placebo. During the study, participants are monitored for adverse events related to CS-1103 through physical exams, electrocardiograms, vital signs, and laboratory tests over three days plus a follow-up on Day 10. Urine samples are collected for 48 hours to measure methamphetamine excretion, and blood and urine samples are taken to track CS-1103 levels over 48 hours. The total participation time includes initial dosing and monitoring through Day 10.

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