NCT06721494

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Clear Scientific, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Methamphetamine Intoxication
• Methamphetamine Disorders
• Methamphetamine Abuse

Interventions

Type	Name	Description
DRUG	Methamphetamine	Methamphetamine HCl for intravenous administration
DRUG	Sterile Saline	Sterile Saline for intravenous administration
DRUG	CS-1103	CS-1103 for intravenous administration

Timeline

• Start date: 2026-02-05
• Primary completion: 2026-09-04
• Completion: 2026-09-11
• First posted: 2024-12-06
• Last updated: 2026-01-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study