drugset / Trial / NCT03336866
Study of Antibody for Methamphetamine Outpatient Therapy
Phase 1/2
Completed
77 enrolled
InterveXion Therapeutics, LLC
National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study evaluates the ability of IXT-m200 to change methamphetamine concentrations in blood and alter the way methamphetamine feels. Participants will receive either placebo, a low or high dose of IXT-m200, in addition to methamphetamine challenge doses.
Timeline
- Start
- 2018-05-03
- Primary completion
- 2020-11-23
- Completion
- 2021-03-09
Outcome
Met primary endpoint
registry Placebo vs IXT-m200, 6 mg/kg; p <0.0001 NCT03336866 ↗
registry Placebo vs IXT-m200, 20 mg/kg; p <0.0001 NCT03336866 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DEVEXTINETUG | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | DEVEXTINETUG | Monoclonal antibody | 20 mg/kg | Intravenous |