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

Phase 2

Not yet recruiting

• Conditions: Methamphetamine Intoxication; Methamphetamine Disorders; Methamphetamine Abuse
• Interventions: Drug: Methamphetamine; Drug: Sterile Saline; Drug: CS-1103

• Registration Number: NCT06721494
• Lead Sponsor: Clear Scientific, Inc.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-03
• Study First Submitted QC: 2024-12-03
• Study First Posted: 2024-12-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-30
• Last Update Posted: 2025-05-04
• Study Start: 2025-06-02
• Primary Completion: 2026-01-06
• Study Completion: 2026-02-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 50 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Methamphetamine	Participants receive methamphetamine HCl (30 mg) followed by placebo (saline).
Placebo	Sterile Saline	Participants receive methamphetamine HCl (30 mg) followed by placebo (saline).
Active	Methamphetamine	Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103
Active	CS-1103	Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Time course of CS-1103 blood and urine concentrations	48 hours	Measurement of plasma and urine concentrations of CS-1103

Trial Locations

Locations (1)

California Clinical Trials Medical Group; 🇺🇸 Glendale, California, United States