Safety, Tolerability, and Pharmacokinetics of IXT-m200

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose Intravenous Study to Evaluate the Safety and Pharmacokinetics of IXT-m200 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: IXT-m200
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Eligible participants will: Be 18-65 years of age, inclusive, at the time of study consent; Be able and willing to read, comprehend, and give Authorization for Use/Disclosure of Health Information (HIPAA) and informed consent; Be healthy, based on the pre-study medical evaluation (medical history and physical exam, vital signs, ECG, and clinical laboratory evaluations); Be willing to comply with study instructions and dosing, agree to make all appointments, and complete the entire course of the study; Be of nonchildbearing potential or agree to use protocol-specified method(s) of birth control throughout study participation; Agree to adhere to Lifestyle Considerations throughout study duration. Exclusion Criteria: - Eligible participants will NOT: Have a history of treatment with a monoclonal antibody in the past year; 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; Have a history of alcohol and/or drug use disorder, as determined by DSM-5 criteria; Have a history of stimulant use, including methamphetamine and amphetamine; 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); Have a positive drug screen for any psychoactive substances (legal or nonlegal) on Day 1 prior to dosing; Have a history of severe allergy (rash, hives, breathing difficulty, etc) to any medications; Have a history of allergic or environmental bronchial asthma within the past 3 years; 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; Have a history of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological conditions; Have a planned or scheduled surgical procedure during the study; Have recently donated blood or plasma (within 30 days of study drug dose); Have a current diagnosis of anorexia nervosa or bulimia disorder; 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; Be pregnant or lactating; In the Investigator's or Sponsor's (or designee) opinion, be inappropriate for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IXT-m200<br>3 g of IXT-m200 given once by 30-min intravenous infusion | Drug: IXT-m200<br>* Anti-methamphetamine chimeric monoclonal antibody (mAb)<br>* Other names: ch-mAb7F9;|
| Placebo Comparator: Placebo<br>Normal saline | Other: Placebo<br>* Normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-related Adverse Events (AEs) Assessed by Physical Examinations | Physical examinations | 127 days | 
| Number of Participants With Treatment-related AEs Assessed by Vital Signs | Blood pressure, heart rate, and temperature | 127 days | 
| Number of Participants With Treatment-related AEs Assessed by ECG | Electrocardiogram | 30 min post-dose completion | 
| Number of Participants With Treatment-related AEs Assessed by Clinical Laboratory Testing | Clinical laboratory testing | 64 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Course of IXT-m200 Concentrations | IXT-m200 concentrations over time | 127 days |