Safety, Tolerability, and Pharmacokinetics of IXT-m200
Condition: Healthy
Intervention: IXT-m200; Placebo
Intervention description: Anti-methamphetamine chimeric monoclonal antibody (mAb); Normal saline
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

Eligibility criteria:

        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.