Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for DISLIKE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for FEEL over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for GOOD over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for HIGH over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for LIKE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for MORE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for STIMULATED over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

Number of serious adverse events (SAEs) as identified by physical examinations and vital sign, adverse event, ECG, and clinical laboratory testing, and immune response by measurement of anti-IXT-m200 antibody levels.

Measured by serum concentrations of IXT-m200 over time

Single 20 mg/kg intravenous dose of IXT-m200

Total of all reporting groups

Single 20 mg/kg intravenous dose of IXT-m200

METH Cmax following IXT-m200 dosing on each METH Challenge Day.

This outcome used the pharmacokinetic (PK) set. The PK set consisted of all subjects in the safety analysis set for whom at least 1 PK parameter could be calculated for METH or IXT-m200.

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for CRAVE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for DISLIKE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for FEEL over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for GOOD over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for HIGH over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for LIKE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for MORE over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.

Drug effects questionnaires (visual analog scales with range from 0 (no effect) to 100 (maximum effect)) were administered following weekly doses of methamphetamine starting on Day 5, one day after IXT-m200 or placebo administration. Participants were asked questions assessing subjective effects for STIMULATED over 180 minutes. Values were calculated as an area under the curve by using the trapezoidal rule; time 0 was set to 0 on the effect scale (at time of methamphetamine administration) and the area was calculated through 180 min post-dose. Lower values would indicate less drug effect (better) than higher values indicating larger drug effect (worse).

The pharmacodynamic (PD) analysis set included 54 (96.4%) subjects for at least one time point. Two subjects were excluded after IXT-m200 dosing from the PD set due to having no measures for PD data due to early discontinuation. Other subjects were excluded for having no PD data at subsequent timepoints due to leaving the inpatient portion of the study early.

Number of serious adverse events (SAEs) as identified by physical examinations and vital sign, adverse event, ECG, and clinical laboratory testing, and immune response by measurement of anti-IXT-m200 antibody levels.

All subjects who received a dose of IXT-m200 or placebo on Day 4.

Measured by serum concentrations of IXT-m200 over time

All subjects who had quantifiable serum concentrations of IXT-m200 above the lower limit of quantitation (<1250 ng/mL) starting at the first time point within 2.25 hr post-dose.

Normal saline

Placebo: Normal saline

Single 6 mg/kg intravenous dose of IXT-m200

IXT-m200: IXT-m200 is an anti-methamphetamine monoclonal antibody

Single 20 mg/kg intravenous dose of IXT-m200