NCT05034874

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

A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200 in Treatment-Seeking Individuals With Methamphetamine Use Disorder

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: InterveXion Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2022-06-09
• Primary completion: 2023-09-11
• Completion: 2023-11-07
• First posted: 2021-09-05
• Last updated: 2024-10-04
• Results posted: 2024-10-04

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study