Healthy
Conditions
Brief summary
Approximately 9 participants will be enrolled in the study in a single cohort. Participants will be randomized to 3 g IXT-m200 or placebo at 7:2. Each will receive their dose as a 30-min intravenous infusion, then remain at the study site overnight to complete Day 1 and Day 2 assessments (e.g., electrocardiogram (ECG), laboratory assessments, blood draws, and vital signs). Following discharge on Day 2, participants will return to the clinic for follow-up pharmacokinetic (PK) and safety assessments on Day 8, then every 1-3 weeks thereafter until Day 127.
Interventions
DRUGIXT-m200
Anti-methamphetamine chimeric monoclonal antibody (mAb)
OTHERPlacebo
Normal saline
Sponsors
National Institute on Drug Abuse (NIDA)
InterveXion Therapeutics, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\- Eligible participants will: 1. Be 18-65 years of age, inclusive, at the time of study consent; 2. Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent; 3. Be healthy, based on the pre-study medical evaluation (medical history and physical exam, vital signs, ECG, and clinical laboratory evaluations); 4. Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study; 5. Be of nonchildbearing potential or agree to use protocol-specified method(s) of birth control throughout study participation; 6. Agree to adhere to Lifestyle Considerations throughout study duration.
Exclusion criteria
\- Eligible participants will NOT: 1. Have a history of treatment with a monoclonal antibody in the past year; 2. Have a known contraindication or sensitivity to IXT-m200 based on known allergies to other mAbs, any inactive ingredient of IXT-m200, or any other products required for the study procedures; 3. Have a history of alcohol and/or drug use disorder, as determined by DSM-5 criteria; 4. Have a history of stimulant use, including methamphetamine and amphetamine; 5. Be currently taking certain other drugs and medications, including: designer drugs (e.g., 3,4-methylenedioxyMETH (MDMA, Ecstasy, Adam, XTC) and its N-dimethyl metabolite methylenedioxyamphetamine (MDA), anti-orexigenic drugs (including over-the-counter medications for weight loss), or be chronic users of phenethylamine compounds (e.g., phenylpropanolamine, ephedrine, pseudoephedrine, amphetamine, phentermine, phenmetrazine, methylphenidate, diethylpropion, and propylhexedrine); 6. Have a positive drug screen for any psychoactive substances (legal or nonlegal) on Day 1 prior to dosing; 7. Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications; 8. Have a history of allergic or environmental bronchial asthma within the past 3 years; 9. Have a clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, gastrointestinal, cardiovascular, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous (eg psychiatric conditions), or hematologic systems, or recent clinically significant surgery; 10. Have a history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions; 11. Have a planned or scheduled surgical procedure during the study; 12. Have recently donated blood or plasma (within 30 days of study drug dose); 13. Have a current diagnosis of anorexia nervosa or bulimia disorder; 14. Be currently participating or has participated within the last 30 days prior to the start of this study in a drug, device, or other interventional research study; 15. Be pregnant or lactating; 16. In the Investigator's or Sponsor's (or designee) opinion, be inappropriate for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related AEs Assessed by Vital Signs | 127 days | Blood pressure, heart rate, and temperature |
| Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations | 127 days | Physical examinations |
| Number of Participants With Treatment-related AEs Assessed by ECG | 30 min post-dose completion | Electrocardiogram |
| Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing | 64 days | Clinical laboratory testing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time Course of IXT-m200 Concentrations | 127 days | IXT-m200 concentrations over time |
Countries
United States
Participant flow
Pre-assignment details
Participants underwent screening procedures to check eligibility criteria within 30 days prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| IXT-m200 3 g of IXT-m200 given once by 30-min intravenous infusion
IXT-m200: Anti-methamphetamine chimeric monoclonal antibody (mAb) | 7 |
| Placebo Normal saline
Placebo: Normal saline | 2 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | Total | Placebo | IXT-m200 |
|---|---|---|---|
| Age, Continuous | 42.0 years STANDARD_DEVIATION 8.94 | 42.5 years STANDARD_DEVIATION 13.44 | 41.9 years STANDARD_DEVIATION 8.75 |
| BMI | 28.52 kg/m^2 STANDARD_DEVIATION 3.72 | 24.38 kg/m^2 STANDARD_DEVIATION 4.91 | 29.7 kg/m^2 STANDARD_DEVIATION 2.67 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 169.59 cm STANDARD_DEVIATION 7.5 | 163 cm STANDARD_DEVIATION 11.31 | 171.5 cm STANDARD_DEVIATION 5.91 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 9 participants | 2 participants | 7 participants |
| Sex: Female, Male Female | 5 Participants | 0 Participants | 5 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 2 Participants |
| Weight | 82.21 kg STANDARD_DEVIATION 13.46 | 64 kg STANDARD_DEVIATION 4.1 | 87.41 kg STANDARD_DEVIATION 9.83 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 2 |
| other Total, other adverse events | 4 / 7 | 2 / 2 |
| serious Total, serious adverse events | 0 / 7 | 0 / 2 |
Outcome results
Primary
Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations
Physical examinations
Time frame: 127 days
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IXT-m200 | Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations | 0 Participants |
| Placebo | Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations | 0 Participants |
Primary
Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing
Clinical laboratory testing
Time frame: 64 days
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IXT-m200 | Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing | 1 Participants |
| Placebo | Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing | 0 Participants |
Primary
Number of Participants With Treatment-related AEs Assessed by ECG
Electrocardiogram
Time frame: 30 min post-dose completion
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IXT-m200 | Number of Participants With Treatment-related AEs Assessed by ECG | 0 Participants |
| Placebo | Number of Participants With Treatment-related AEs Assessed by ECG | 0 Participants |
Primary
Number of Participants With Treatment-related AEs Assessed by Vital Signs
Blood pressure, heart rate, and temperature
Time frame: 127 days
Population: All participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IXT-m200 | Number of Participants With Treatment-related AEs Assessed by Vital Signs | 0 Participants |
| Placebo | Number of Participants With Treatment-related AEs Assessed by Vital Signs | 0 Participants |
Secondary
Time Course of IXT-m200 Concentrations
IXT-m200 concentrations over time
Time frame: 127 days
Population: All participants receiving IXT-m200
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IXT-m200 | Time Course of IXT-m200 Concentrations | Pre-dose | 0 mg/L | Standard Deviation 0 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | 1 hr post-dose | 728 mg/L | Standard Deviation 157 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | 4 hr post-dose | 705 mg/L | Standard Deviation 100 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | 8 hr post-dose | 632 mg/L | Standard Deviation 104 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 2 | 632 mg/L | Standard Deviation 132 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 8 | 316 mg/L | Standard Deviation 62.6 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 15 | 257 mg/L | Standard Deviation 31 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 22 | 194 mg/L | Standard Deviation 48 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 29 | 155 mg/L | Standard Deviation 50.9 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 36 | 109 mg/L | Standard Deviation 22.5 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 43 | 84.1 mg/L | Standard Deviation 14.8 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 64 | 37.4 mg/L | Standard Deviation 12.2 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 85 | 13.5 mg/L | Standard Deviation 4.3 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 106 | 6.92 mg/L | Standard Deviation 1.98 |
| IXT-m200 | Time Course of IXT-m200 Concentrations | Day 127 | 3.65 mg/L | Standard Deviation 1.4 |