Trial Outcomes & Findings for Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose (NCT NCT04715230)
NCT ID: NCT04715230
Last Updated: 2023-11-18
Results Overview
Blood pressure, heart rate, and temperature
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
28 days
Results posted on
2023-11-18
Participant Flow
Participant milestones
| Measure |
IXT-m200 Low Dose (0.5 g)
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.
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.
|
IXT-m200 High Dose (2 g)
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
4
|
|
Overall Study
COMPLETED
|
7
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
1
|
Reasons for withdrawal
| Measure |
IXT-m200 Low Dose (0.5 g)
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.
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.
|
IXT-m200 High Dose (2 g)
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
1
|
Baseline Characteristics
Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
Baseline characteristics by cohort
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.3 years
STANDARD_DEVIATION 6.23 • n=5 Participants
|
36.8 years
STANDARD_DEVIATION 6.48 • n=7 Participants
|
35.3 years
STANDARD_DEVIATION 7.17 • n=5 Participants
|
35.5 years
STANDARD_DEVIATION 6.10 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
8 participants
n=7 Participants
|
4 participants
n=5 Participants
|
20 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: All participants receiving a dose of IXT-m200 or TAU.
Blood pressure, heart rate, and temperature
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Number of Patients With Treatment-related Adverse Events (AEs) as Measured by Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: All participants receiving a dose of IXT-m200 or TAU
Physical examinations
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Number of Patients With Treatment-related AEs as Measured by Physical Examinations
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: All participants receiving a dose of IXT-m200 or TAU.
Clinical laboratory testing
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Number of Patients With Treatment-related AEs as Measured by Clinical Laboratory Testing
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 hoursPopulation: All participants receiving a dose of IXT-m200 or TAU.
Electrocardiogram
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Number of Patients With Treatment-related AEs as Measured by Electrocardiogram
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.Population: All participants receiving a dose of IXT-m200 or TAU. No further data were collected after participants were discharged. Some time points do not contain results as all participants in that group had been discharged prior to that timepoint or all data were missing.
Agitation/sedation scores over time as measured by Agitation/Calmness Evaluation Score (ACES). The minimum value is 1 (highly agitated) and the highest value is 9 (completely sedated). A score of 3-5 is considered normal.
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Time Course and Degree of Normalization of Agitation
Baseline
|
2.1 score on a scale
Standard Deviation 0.64
|
2. score on a scale
Standard Deviation 0.53
|
2.8 score on a scale
Standard Deviation 0.50
|
|
Time Course and Degree of Normalization of Agitation
0.5 hour
|
4.1 score on a scale
Standard Deviation 1.81
|
3.6 score on a scale
Standard Deviation 1.60
|
3.9 score on a scale
Standard Deviation 1.67
|
|
Time Course and Degree of Normalization of Agitation
1 hour
|
4.6 score on a scale
Standard Deviation 1.92
|
3.9 score on a scale
Standard Deviation 1.81
|
5.8 score on a scale
Standard Deviation 1.89
|
|
Time Course and Degree of Normalization of Agitation
2 hours
|
4.0 score on a scale
Standard Deviation 1.91
|
4.0 score on a scale
Standard Deviation 2.08
|
4.8 score on a scale
Standard Deviation 0.50
|
|
Time Course and Degree of Normalization of Agitation
3 hours
|
7.0 score on a scale
|
3.0 score on a scale
Standard Deviation 2.83
|
—
|
|
Time Course and Degree of Normalization of Agitation
4 hours
|
—
|
1.0 score on a scale
|
—
|
SECONDARY outcome
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.Population: All participants receiving a dose of IXT-m200 or TAU. No further data were collected after participants were discharged. Some time points do not contain results as all participants in that group had been discharged prior to that timepoint or all data were missing.
Blood pressure over time; reported as the number of participants with blood pressure out of normal range (i.e., diastolic \>110 or \<50 mmHg, or systolic \>180 or \<90 mmHg))
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
0.5 hour · Normal
|
8 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
0.5 hour · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
1 hour · Normal
|
8 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
1 hour · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
2 hours · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
2 hours · Normal
|
7 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
1 hour · High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Baseline · High
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Baseline · Normal
|
8 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Baseline · Low
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
0.5 hour · High
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
2 hours · Low
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
3 hours · High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
3 hours · Normal
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
3 hours · Low
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Prior to discharge · High
|
—
|
1 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Prior to discharge · Normal
|
—
|
0 Participants
|
1 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Blood Pressure Over Time
Prior to discharge · Low
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.Population: All participants receiving a dose of IXT-m200 or TAU. No further data were collected after participants were discharged. Some time points do not contain results as all participants in that group had been discharged prior to that timepoint or all data were missing.
Heart rate over time reported as number of participants with heart rate high (\>120 beats/min), normal, or low (\<40 beats/min).
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
2 hours · Normal
|
6 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
2 hours · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
Baseline · High
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
Baseline · Normal
|
8 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
Baseline · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
0.5 hour · High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
0.5 hour · Normal
|
7 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
0.5 hour · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
1 hour · High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
1 hour · Normal
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
1 hour · Low
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
2 hours · High
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
3 hours · High
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
3 hours · Normal
|
1 Participants
|
2 Participants
|
—
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
3 hours · Low
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
Prior to discharge · High
|
—
|
0 Participants
|
0 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
Prior to discharge · Normal
|
—
|
1 Participants
|
1 Participants
|
|
Number of Participants at Certain Degrees of Normalization of Heart Rate Over Time
Prior to discharge · Low
|
—
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and hours 0.5, 1, 2, 3, 4, and 8 post-dose or until discharge.Population: All participants receiving a dose of IXT-m200 or TAU. No further data were collected after participants were discharged. Some time points do not contain results as all participants in that group had been discharged prior to that timepoint or all data were missing.
Temperature over time
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=6 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=6 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Time Course and Degree of Normalization of Temperature
3 hours
|
99.10 degrees Fahrenheit
|
99.50 degrees Fahrenheit
|
—
|
|
Time Course and Degree of Normalization of Temperature
Baseline
|
98.2 degrees Fahrenheit
Standard Deviation 0.62
|
98.25 degrees Fahrenheit
Standard Deviation 0.345
|
98.10 degrees Fahrenheit
Standard Deviation 0.424
|
|
Time Course and Degree of Normalization of Temperature
0.5 hour
|
98.05 degrees Fahrenheit
Standard Deviation 0.495
|
98.52 degrees Fahrenheit
Standard Deviation 0.476
|
—
|
|
Time Course and Degree of Normalization of Temperature
1 hour
|
98.45 degrees Fahrenheit
Standard Deviation 0.778
|
98.48 degrees Fahrenheit
Standard Deviation 0.562
|
97.7 degrees Fahrenheit
|
|
Time Course and Degree of Normalization of Temperature
2 hours
|
98.50 degrees Fahrenheit
Standard Deviation 1.414
|
98.38 degrees Fahrenheit
Standard Deviation 0.907
|
97.7 degrees Fahrenheit
|
|
Time Course and Degree of Normalization of Temperature
Discharge
|
97.40 degrees Fahrenheit
Standard Deviation 0.141
|
98.0 degrees Fahrenheit
|
98.10 degrees Fahrenheit
|
SECONDARY outcome
Timeframe: 8 hoursPopulation: All participants receiving a dose of IXT-m200 or TAU.
Number of participants that need rescue medications to treat: * agitation, dysphoria, or psychosis (central nervous system toxicity) * hypertension, tachycardia, or other cardiovascular instability (cardiovascular toxicity)
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Number of Participants Requiring Rescue Medications for Psychiatric or Cardiovascular Manifestations of METH Toxicity
Did not require rescue medications
|
8 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants Requiring Rescue Medications for Psychiatric or Cardiovascular Manifestations of METH Toxicity
Required rescue medications
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Start of treatment until dischargePopulation: All participants receiving a dose of IXT-m200 or TAU.
ED length of stay as measured by discharge time minus start of treatment time
Outcome measures
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 Participants
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 Participants
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 Participants
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Length of Patient Stay in the ED
|
8.940 hours
Standard Deviation 5.6843
|
8.031 hours
Standard Deviation 6.0973
|
10.196 hours
Standard Deviation 8.0826
|
Adverse Events
IXT-m200 Low Dose (0.5 g)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
IXT-m200 High Dose (2 g)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Treatment as Usual (TAU)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 participants at risk
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 participants at risk
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 participants at risk
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
General disorders
Mass
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
|
Investigations
Liver function test abnormal
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
Other adverse events
| Measure |
IXT-m200 Low Dose (0.5 g)
n=8 participants at risk
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.
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.
|
IXT-m200 High Dose (2 g)
n=8 participants at risk
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 20 min for the 2-g doses.
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.
|
Treatment as Usual (TAU)
n=4 participants at risk
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.
Lorazepam: Lorazepam is a benzodiazepine that is safe and commonly used to treat agitation and dysphoria in the emergency setting.
Haloperidol: Haloperidol is commonly used to treat agitation due to psychosis.
|
|---|---|---|---|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • 28 days
|
0.00%
0/8 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
|
Psychiatric disorders
Agitation
|
12.5%
1/8 • Number of events 1 • 28 days
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/4 • 28 days
|
|
Psychiatric disorders
Hallucination, auditory
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
|
Psychiatric disorders
Hallucinations, mixed
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
|
Psychiatric disorders
Suicidal ideation
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
|
Infections and infestations
COVID-19
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/8 • 28 days
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/4 • 28 days
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • 28 days
|
0.00%
0/8 • 28 days
|
0.00%
0/4 • 28 days
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/8 • 28 days
|
0.00%
0/8 • 28 days
|
25.0%
1/4 • Number of events 1 • 28 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI must provide Sponsor opportunity to review proposed publications/disclosures before submission/disclosure. The first publication is to be a joint publication involving all sites, with Sponsor in control of such publication. Afterward, and if such publication is not made within 12 months following finalization of the clinical study report or termination of the study at all sites, PI may publish separately.
- Publication restrictions are in place
Restriction type: OTHER