Safety, Tolerability, and Pharmacokinetics of IXT-m200

NCT05027451 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: M200C-2102U01DA045366
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Time Course of IXT-m200 Concentrations

  127 days

Study Arms (2)

IXT-m200

EXPERIMENTAL

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

Drug: IXT-m200

Placebo

PLACEBO COMPARATOR

Normal saline

Other: Placebo

Interventions

IXT-m200 DRUG

Anti-methamphetamine chimeric monoclonal antibody (mAb)

Also known as: ch-mAb7F9

IXT-m200

Placebo OTHER

Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Clinilabs Drug Development Corporation

Eatontown, New Jersey, 07724, United States

Location

Results Point of Contact

• Title: Chief Operating Officer
• Organization: InterveXion Therapeutics, LLC

misty.stevens@intervexion.com

501-554-2377

Study Officials

• Chief Medical Officer

  InterveXion Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 30, 2021
• Study Start: October 25, 2021
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: June 1, 2023
• Results First Posted: June 1, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: These datasets will be available for distribution following submission to the FDA of the Clinical Study Report and publication. They will be available for 2 years after the initial publication.
• Access Criteria: These datasets and associated documentation will be made available on CD by the Sponsor to requestors under a data sharing agreement that provides for: (1) a commitment to using the data only for research purposes; (2) a commitment to securing the data using appropriate computer technology and not distributing to third parties; and (3) a commitment to destroying or returning the data after analyses are completed. Requests should be sent to intervexion@gmail.com.

Locations

US (1)