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

Phase 2RecruitingNCT06721494
Clear Scientific, Inc.40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

40

Conditions

Methamphetamine IntoxicationMethamphetamine DisordersMethamphetamine Abuse

Interventions

MethamphetamineDRUG

Methamphetamine HCl for intravenous administration

Sterile SalineDRUG

Sterile Saline for intravenous administration

CS-1103DRUG

CS-1103 for intravenous administration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years
Medical Language ↔ Plain English
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 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.

Locations (1)

California Clinical Trials Medical Group

Glendale, California, United States

RECRUITING

Outcomes

Primary Outcomes

Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations

Physical examinations

Time frame: 3 days plus follow-up on Day 10

Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)

Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted.

Time frame: 3 days plus follow-up on Day 10

Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs

Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature

Time frame: 3 days plus follow-up on Day 10

Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters

Clinical chemistry, hematology, coagulation, and urinalysis

Time frame: 3 days plus follow-up on Day 10

Time course and magnitude of urine excretion of methamphetamine

Measurement of concentration of methamphetamine in urine

Time frame: 48 hours

Secondary Outcomes

Time course of CS-1103 blood and urine concentrations

Measurement of plasma and urine concentrations of CS-1103

Time frame: 48 hours

Central Contacts

Anna Del Rosario, B.S.

CONTACT

617-621-8500adelrosario@clearsci.com

Piercen Oliver, Ph.D.

CONTACT

617-621-8500poliver@clearsci.com
Data from ClinicalTrials.gov

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