Safety, Tolerability, and Pharmacokinetics of IXT-m200

NCT ID: NCT05027451

Last Updated: 2023-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-25
• Study Completion Date: 2022-03-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

IXT-m200

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

Group Type: EXPERIMENTAL

IXT-m200

Intervention Type: DRUG

Anti-methamphetamine chimeric monoclonal antibody (mAb)

Placebo

Normal saline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Normal saline

Interventions

IXT-m200

Anti-methamphetamine chimeric monoclonal antibody (mAb)

Intervention Type: DRUG

Placebo

Normal saline

Intervention Type: OTHER

Other Intervention Names

ch-mAb7F9

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

InterveXion Therapeutics, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

InterveXion Therapeutics

Locations

Clinilabs Drug Development Corporation

Eatontown, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

U01DA045366

Identifier Type: NIH

Identifier Source: secondary_id

View Link

M200C-2102

Identifier Type: -

Identifier Source: org_study_id