drugset / Trial / NCT05034874
Multiple-Dose Study to Evaluate the Safety and Efficacy of IXT-m200
Phase 2
Terminated
61 enrolled
InterveXion Therapeutics, LLC
National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupTriple-blindTreatment
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).
Timeline
- Start
- 2022-06-09
- Primary completion
- 2023-09-11
- Completion
- 2023-11-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DEVEXTINETUG | Monoclonal antibody | 1.5 g | Intravenous |
| Subject | DEVEXTINETUG | Monoclonal antibody | 3 g | Intravenous |