Safety Study of Ch-mAb7F9 for Methamphetamine Abuse

NCT01603147 | Completed Phase 1 DMC

• 2 other identifiers: IXT TOA62936R01DA031944
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.Phase 1a, randomized, placebo-controlled, first-in-human (FIH) study of intravenously administered ch-mAb7F9. The study will be a double-blind, dose-escalation study. Each subject will receive a single dose of ch-mAb7F9 or placebo (saline).

Conditions

Methamphetamine Abuse

Keywords

methamphetamine; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Safety

  The primary outcome is to determine the safety and tolerability of single, ascending intravenous doses of ch-mAb7F9 in healthy subjects via physical examinations and adverse event, vital sign, electrocardiogram (ECG), and clinical laboratory testing.

  21 weeks

Secondary Outcomes (2)

• Pharmacokinetics

  21 weeks

• Immunogenicity

  21 weeks

Study Arms (2)

Saline

PLACEBO COMPARATOR

A total of 10 subjects will receive placebo

Biological: normal saline

ch-mAb7F9

EXPERIMENTAL

The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively.

Biological: ch-mAb7f9

Interventions

normal saline BIOLOGICAL

saline 225 ml

Saline

ch-mAb7f9 BIOLOGICAL

The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. Volume to be administered 225 ml

ch-mAb7F9

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subject voluntarily agrees to participate in this study and signs an IRB-approved informed consent form prior to performing any of the screening procedures.
• Healthy, determined by the PI based on pre-study medical evaluation (medical history and physical examination, vital signs, ECG, and clinical laboratory evaluations).
• Males or females between 18 to 50 years of age, inclusive.
• The following applies to female subjects:
• \- Nonchildbearing potential (surgically sterile \[hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/occlusion\] or post-menopausal 1 year with follicle stimulating hormone \[FSH\] \> 40 U/L).
• \- Nonpregnant, nonlactating females of childbearing age who agree to use medically acceptable forms of birth control (oral contraceptive pills; contraceptive patches; vaginal ring; diaphragm, sponge, or condom with spermicide; hormone injection; or intrauterine device) from screening to end of study follow-up, or whose partner has had a vasectomy.
• The following applies to 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.
• Agree not to donate sperm for 90 days post dose.
• Body mass index (BMI) between 18.5 and 30.5 kg/m2, inclusive, at screening. Body weight ≥ 50 kg and ≤ 100 kg at screening.
• Nonsmokers or light smokers (\< 10 cigarettes per day) able to refrain from smoking during the in-house period.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• A history of treatment with a monoclonal antibody in the past year,
• likely allergy or sensitivity to ch-mAb7F9 based on known allergies to other mAbs, or which, in the opinion of the Principal Investigator (PI), suggests an increased potential for an adverse hypersensitivity to ch-mAb7F9,
• a history of severe allergy (rash, hives, breathing difficulty, etc.) to any medications, either prescription or nonprescription, including dietary supplements or herbal medications,
• a history of allergic or environmental bronchial asthma,
• 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, or hematologic systems, or recent clinically significant surgery,
• a history of seizure, epilepsy, severe head injury in the opinion of the PI, multiple sclerosis, or other known neurological conditions,
• abnormal pre-admission vital signs, physical examination, clinical laboratory, or any safety variable which is considered clinically significant for this population by the PI or Sponsor (or designee), (volunteers who have or are suspected to have Gilbert's syndrome will be discussed on a case by case basis by the PI, Medical Monitor, and Sponsor),
• a planned or scheduled surgical procedure during the study,
• a clinically significant mental or physical illness within 1 year prior to the first dose, including a history of alcohol and/or drug abuse (DSM IV criteria) within 1 year prior to the first dose of study medication,
• any history of stimulant use or abuse, including methamphetamine, amphetamine, or MDMA (ecstasy),
• a recent (within 30 days of the first dose of study medication) donation of plasma or blood,
• treatment with any medications, either prescription or nonprescription, including dietary supplements or herbal medications, within 14 days prior to the first dose of study medication (exceptions are nonprescription topical medications that are not systemically absorbed, acetaminophen, or vitamins at recommended daily doses),
• ingestion of any known hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, St. John's Wort, etc.) within a period of 90 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,

Sponsors & Collaborators

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

Study Sites (1)

Quintiles Phase 1 Services

Overland Park, Kansas, 66211, United States

Location

Related Publications (1)

• Harris AC, LeSage MG, Shelley D, Perry JL, Pentel PR, Owens SM. The anti-(+)-methamphetamine monoclonal antibody mAb7F9 attenuates acute (+)-methamphetamine effects on intracranial self-stimulation in rats. PLoS One. 2015 Mar 5;10(3):e0118787. doi: 10.1371/journal.pone.0118787. eCollection 2015.

  PMID: 25742165 DERIVED

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

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

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 22, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 13, 2014

Record last verified: 2014-05

Locations

US (1)