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Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200

NCT05034874 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2024-10-04

Study results available
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Summary

This Phase 2 study will evaluate the safety and efficacy of monthly intravenous doses of IXT-m200 in treatment-seeking individuals with methamphetamine (METH) use disorder. The hypothesis are that following an initial relapse, IXT-m200 will reduce the occurrence of stimulant-positive saliva samples compared to placebo and improve the signs and symptoms of METH Use Disorder (MUD).

Conditions

  • Methamphetamine-dependence
  • Methamphetamine Abuse

Interventions

DRUG

IXT-m200

IXT-m200 binds METH with high selectivity and affinity. The product contains a murine METH-binding variable region and the constant domains of a human immunoglobulin G (IgG) 2κ. This antibody isotype was chosen because of the lower risk of immune response compared to an IgG1 or IgG3. IXT-m200 targets METH, does not rely on binding to any endogenous target for its action, and has been well-tolerated in previous clinical studies.

OTHER

Placebo

Saline

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • InterveXion Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · InterveXion Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-09
Primary Completion
2023-09-11
Completion
2023-11-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05034874 on ClinicalTrials.gov