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Monoclonal Antibodies

IXT-m200 for Methamphetamine Intoxication (Meth-OD Trial)

Phase 2
Waitlist Available
Research Sponsored by InterveXion Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing IXT-m200, a new antibody treatment, on patients with mild to moderate methamphetamine poisoning. The treatment works by using antibodies to attach to methamphetamine, which may reduce its harmful effects. The study aims to see if this treatment is safe and effective. Vaccines and monoclonal antibodies for treatment of methamphetamine abuse are being tested.

Eligible Conditions
  • Methamphetamine Intoxication

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~start of treatment until discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and start of treatment until discharge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients With Treatment-related AEs as Measured by Clinical Laboratory Testing
Number of Patients With Treatment-related AEs as Measured by Electrocardiogram
Number of Patients With Treatment-related AEs as Measured by Physical Examinations
+1 more
Secondary study objectives
Number of Participants Requiring Rescue Medications for Psychiatric or Cardiovascular Manifestations of METH Toxicity
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
+2 more
Other study objectives
Length of Patient Stay in the ED

Side effects data

From 2021 Phase 1 & 2 trial • 77 Patients • NCT03336866
72%
Euphoric mood
44%
Palpitations
33%
Injection site pain
33%
Hypervigilance
33%
Headache
28%
Nausea
28%
Tachycardia
17%
Catheter site pain
17%
Feeling hot
17%
Hyperhidrosis
17%
Dry mouth
11%
Influenza like illness
11%
Vomiting
11%
Abdominal discomfort
11%
Tremor
6%
Vibratory sense increased
6%
Cellulitis
6%
Feeling abnormal
6%
Skin laceration
6%
Haematuria
6%
Constipation
6%
Dizziness
6%
Vision blurred
6%
Dry skin
6%
Bruxism
6%
Mood altered
6%
Contusion
6%
Blood creatine phosphokinase increased
6%
Glycosylated haemoglobin increased
6%
Eye contusion
6%
Ear pruritis
6%
Toothache
6%
Abdominal distension
6%
Catheter site inflammation
6%
Injection site erythema
6%
Seasonal allergy
6%
Cough
6%
Nasal disorder
6%
Pain
6%
Catheter site nodule
6%
Gastroenteritis
6%
Diarrhoea
6%
Musculoskeletal pain
6%
Sinus headache
6%
Somnolence
6%
Restlessness
6%
Nasal dryness
6%
Rhinorrhoea
6%
Sinus congestion
6%
Tachypnoea
6%
Acne
6%
Dermatitis contact
6%
Rash macular
6%
Skin lesion
6%
Drug abuser
6%
Phlebitis
6%
Visual impairment
6%
Feeling of relaxation
6%
Neck pain
6%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IXT-m200, 20 mg/kg: Day 4-126
IXT-m200, 6 mg/kg: Day 4-126
Placebo: Day 4-126
All Subjects: Day 1-3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: IXT-m200Experimental Treatment1 Intervention
IXT-m200 is a high-affinity chimeric anti-METH monoclonal antibody that is well-tolerated in healthy volunteers and in non-intoxicated people with METH use disorder. The total dose will be given over 10 min for the 0.5-g dose and over 20 min for the 1-, 1.5-, and 2-g doses.
Group II: Treatment as Usual (TAU)Active Control2 Interventions
Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting. Haloperidol is commonly used to treat agitation due to psychosis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IXT-m200
2021
Completed Phase 2
~90

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,586 Previous Clinical Trials
3,328,510 Total Patients Enrolled
1 Trials studying Methamphetamine Intoxication
34 Patients Enrolled for Methamphetamine Intoxication
InterveXion Therapeutics, LLCLead Sponsor
4 Previous Clinical Trials
189 Total Patients Enrolled
Chief Medical OfficerStudy DirectorInterveXion Therapeutics
126 Previous Clinical Trials
21,971 Total Patients Enrolled
~5 spots leftby Nov 2025
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