Study of Antibody for Methamphetamine Outpatient Therapy

NCT03336866 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: M200C-1801U01DA045366
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 2

Brief Summary

This study evaluates the ability of IXT-m200 to change methamphetamine concentrations in blood and alter the way methamphetamine feels. Participants will receive either placebo, a low or high dose of IXT-m200, in addition to methamphetamine challenge doses.

Conditions

Methamphetamine-dependence; Methamphetamine Abuse

Outcome Measures

Primary Outcomes (2)

• Change in Plasma Methamphetamine (METH) Area Under the Curve (AUCinf) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200

  METH AUCinf following IXT-m200 dosing on each METH Challenge Day.

  Day 1, 5, 12, 19, and 26

• Change in Plasma Methamphetamine (METH) Maximum Concentration (Cmax) Resulting From METH Challenge Doses Following Single IV Doses of IXT-m200

  METH Cmax following IXT-m200 dosing on each METH Challenge Day.

  Day 1, 5, 12, 19, and 26

Secondary Outcomes (10)

• Change in Subjective Effects for CRAVE of METH Challenge Doses

  Day 1, 5, 12, 19, and 26

• Change in Subjective Effects for DISLIKE of METH Challenge Doses

  Day 1, 5, 12, 19, and 26

• Change in Subjective Effects for FEEL of METH Challenge Doses

  Day 1, 5, 12, 19, and 26

• Change in Subjective Effects for GOOD of METH Challenge Doses

  Day 1, 5, 12, 19, and 26

• Change in Subjective Effects for HIGH of METH Challenge Doses

  Day 1, 5, 12, 19, and 26

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Placebo

IXT-m200

EXPERIMENTAL

Single 6 or 20 mg/kg intravenous dose of IXT-m200

Drug: IXT-m200

Interventions

Placebo DRUG

Normal saline

Placebo

IXT-m200 DRUG

IXT-m200 is an anti-methamphetamine monoclonal antibody

Also known as: ch-mAb7F9

IXT-m200

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject voluntarily agrees to participate in this study and signs an informed consent form.
• Subject must be able to verbalize understanding of the consent forms, provide written informed consent, and verbalize willingness to complete study procedures.
• Males or females between 21 to 50 years of age, inclusive. Female subjects should be of non-childbearing potential or, they should be nonpregnant, nonlactating, and agree to use medically acceptable forms of birth control from screening to end-of-study follow-up, or have a partner who has had a vasectomy. Male subjects need to have had a vasectomy or agree to use a condom and spermicide in addition to their female partners using a form of birth control. They should agree not to donate sperm for 90 days post IXT-m200 dose.
• Body mass index (BMI) between 18.0 and 35.0 kg/m2. Body weight ≥ 50 kg and ≤ 100 kg.
• Subjects have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase) \< 3 times the upper limit of normal, and b) kidney function tests (creatinine and BUN) \< 2 times the upper limit of normal.
• Subjects meet Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for METH use disorder and are not seeking treatment at the time of the study.
• Subjects will be experienced METH users with a history of non-therapeutic METH use for 2 or more years. Subjects must have experience with smoking or IV injection of METH.
• Current METH use (past 30 days) less than daily, self-reported and documented by calendar-based timeline follow-back.
• Primary current (past 30 days) route of METH self-administration other than IV (ie, smoking, snorting, or oral).
• Subjects agree not to take METH from any source outside of the study during their participation in the study. Subjects agree not to take substances that are structurally similar to METH.
• Subjects must provide a negative urine sample prior to admission to the unit on Day -1 for the study.

You may not qualify if:

• Subjects who have been treated with a monoclonal antibody (mAb) in the past year.
• Known or suspected allergy sensitivity to IXT-m200 based on known allergies to other mAbs.
• History of severe allergy (rash, hives, breathing difficulty, etc) to any medications.
• History of allergic or environmental bronchial asthma.
• Clinically significant history of or current abnormality or disease of any organ system, including renal, hepatic, GI, cardiovascular, pulmonary (including chronic asthma), endocrine (eg, diabetes), central nervous, or hematologic systems, or recent clinically significant surgery.
• Current diagnosis or history of major psychiatric illness in the past two years or other current psychiatric condition requiring medication, other than methamphetamine dependence.
• Considered by the PI to be at imminent risk of suicide or injury to self, others, or property, or the subject has attempted suicide with the past year. Past year history of, or current evidence for, suicidal ideation or those who were actively suicidal based on the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Current dependence on alcohol or heavy use defined as \>28 alcoholic drinks per week if male and \>21 drinks per week if female in last 30 days.
• Current dependence on other drugs except amphetamines, or marijuana and nicotine used in moderate amounts.
• History of seizure, epilepsy, severe head injury with residual neurologic effects, multiple sclerosis, or stroke.
• Abnormal pre-admission vital signs, physical examination, clinical laboratory, ECG, or any safety variable which is considered clinically significant for this population.
• History of cardiovascular disease.
• Treatment with any prescription medications or over the counter nutritional supplements within 14 days prior to the first dose of study medication.
• Ingestion of any approved prescription anti-obesity drug or taken any over-the-counter medication for weight loss within a period of 90 days prior to the first dose of study medication.
• Ingestion or use of any investigational medication or device within 30 days prior to the first dose of study medication.

Sponsors & Collaborators

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

Study Sites (2)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

Limitations and Caveats

All participants were dosed with methamphetamine on a weekly basis following treatment with IXT-m200 or placebo. Thus, safety of IXT-m200 alone cannot be distinguished from the expected adverse events resulting from the methamphetamine doses. Variability of the responses on the drug effects questionnaires was much higher than anticipated. This resulted in insufficient power to detect differences between treated and control groups.

Results Point of Contact

• Title: Chief Operating Officer
• Organization: InterveXion Therapeutics

misty.stevens@intervexion.com

5015542377

Study Officials

• Lynn Webster, MD

  PRA Health Sciences

  PRINCIPAL INVESTIGATOR

• Peter Winkle, MD

  Anaheim Clinical Trials

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2017
• First Posted: November 8, 2017
• Study Start: May 3, 2018
• Primary Completion: November 23, 2020
• Study Completion: March 9, 2021
• Last Updated: March 10, 2022
• Results First Posted: March 10, 2022

Record last verified: 2022-01

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 (2)