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

NCT06721494 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-12

No results posted yet for this study

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

DRUG

Methamphetamine

Methamphetamine HCl for intravenous administration

DRUG

Sterile Saline

Sterile Saline for intravenous administration

DRUG

CS-1103

CS-1103 for intravenous administration

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Clear Scientific, Inc.

    lead INDUSTRY

Principal Investigators

  • Xinhua Li, Ph.D. · Clear Scientific, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-05
Primary Completion
2026-09-04
Completion
2026-09-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06721494 on ClinicalTrials.gov