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

NCT06721494 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: CS-1103-025U01DA058548-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Methamphetamine Intoxication; Methamphetamine Disorders; Methamphetamine Abuse

Outcome Measures

Primary Outcomes (5)

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

  Physical examinations

  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.

  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

  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

  3 days plus follow-up on Day 10

• Time course and magnitude of urine excretion of methamphetamine

  Measurement of concentration of methamphetamine in urine

  48 hours

Secondary Outcomes (1)

• Time course of CS-1103 blood and urine concentrations

  48 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants receive methamphetamine HCl (30 mg) followed by placebo (saline).

Drug: Methamphetamine; Drug: Sterile Saline

Active

ACTIVE COMPARATOR

Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103

Drug: Methamphetamine; Drug: CS-1103

Interventions

Methamphetamine DRUG

Methamphetamine HCl for intravenous administration

Active; Placebo

Sterile Saline DRUG

Sterile Saline for intravenous administration

Placebo

CS-1103 DRUG

CS-1103 for intravenous administration

Active

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants aged 18 to 55 years, inclusive;
• Meets DSM-5 criteria for methamphetamine use disorder;
• Not seeking treatment for methamphetamine use disorder;
• Primary route of methamphetamine self-administration must be intravenous or smoking;
• Able to abstain from methamphetamine without experiencing severe withdrawal;
• A body mass index between 18 to 30 kg/m2, inclusive and a minimum body weight of 50 kg;
• Females must not be lactating and must have a negative pregnancy test during screening and admission.

You may not qualify if:

• Estimated glomerular filtration rate \<60 mL/min/1.73 m2;
• History of cardiovascular disease;
• Current moderate to severe use disorder for alcohol, cannabis, cocaine, opioids, or benzodiazepines;
• History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.

Sponsors & Collaborators

• Clear Scientific, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

California Clinical Trials Medical Group

Glendale, California, 91206, United States

RECRUITING

MeSH Terms

Interventions

Methamphetamine

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Xinhua Li, Ph.D.

  Clear Scientific, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Del Rosario, B.S.

CONTACT

617-621-8500; adelrosario@clearsci.com

Piercen Oliver, Ph.D.

CONTACT

617-621-8500; poliver@clearsci.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: February 5, 2026
• Primary Completion (Estimated): September 4, 2026
• Study Completion (Estimated): September 11, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)