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

Part of paid clinical trials in Glendale, California.

Sponsor
Clear Scientific, Inc.
Study ID
NCT06721494
Phase
PHASE2
Status
Recruiting
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Conditions

  • Methamphetamine Abuse
  • Methamphetamine Disorders
  • Methamphetamine Intoxication

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Methamphetamine — DRUG
    Methamphetamine HCl for intravenous administration
  • Sterile Saline — DRUG
    Sterile Saline for intravenous administration
  • CS-1103 — DRUG
    CS-1103 for intravenous administration

Study Details

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).

Key Dates

Start date
Feb 5, 2026
Status verified
Jan 2026
Primary completion
Sep 4, 2026
Completion
Sep 11, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Participants receive methamphetamine HCl (30 mg) followed by placebo (saline).
  • Active Comparator: Active
    Participants receive methamphetamine HCl (30 mg) followed by one of four doses of CS-1103

Primary Outcome Measure

Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations [ Time Frame: 3 days plus follow-up on Day 10 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
California Clinical Trials Medical GroupGlendaleCalifornia91206
Lev Gertsik, M.D.
[email protected]
888-228-7425

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By research site
California Clinical Trials Medical Group· Glendale, CA

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