Safety, Tolerability, and Pharmacokinetics of IXT-m200

Sponsor
InterveXion Therapeutics, LLC (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05027451
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
9
Enrollment
1
Location
2
Arms
4.3
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Other
Official Title:
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Single-Dose Intravenous Study to Evaluate the Safety and Pharmacokinetics of IXT-m200 in Healthy Participants
Actual Study Start Date :
Oct 1, 2021
Anticipated Primary Completion Date :
Feb 8, 2022
Anticipated Study Completion Date :
Feb 8, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: IXT-m200

3 g of IXT-m200 given once by 30-min intravenous infusion

Drug: IXT-m200
Anti-methamphetamine chimeric monoclonal antibody (mAb)
Other Names:
  • ch-mAb7F9
  • Placebo Comparator: Placebo

    Normal saline

    Other: Placebo
    Normal saline

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with treatment-related adverse events (AEs) assessed by physical examinations [127 days]

      Physical examinations

    2. Number of participants with treatment-related AEs assessed by vital signs [127 days]

      Blood pressure, heart rate, and temperature

    3. Number of participants with treatment-related AEs assessed by ECG [127 days]

      Electrocardiogram

    4. Number of participants with treatment-related AEs assessed by clinical laboratory testing [127 days]

      Clinical laboratory testing

    Secondary Outcome Measures

    1. Time course of IXT-m200 concentrations [127 days]

      IXT-m200 concentrations over time

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Clinilabs Drug Development CorporationEatontownNew JerseyUnited States07724

    Sponsors and Collaborators

    • InterveXion Therapeutics, LLC
    • National Institute on Drug Abuse (NIDA)

    Investigators

    • Study Director: Chief Medical Officer, InterveXion Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    InterveXion Therapeutics, LLC
    ClinicalTrials.gov Identifier:
    NCT05027451
    Other Study ID Numbers:
    • M200C-2102
    • U01DA045366
    First Posted:
    Aug 30, 2021
    Last Update Posted:
    Oct 8, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 8, 2021