Evidence map›Paper›PMID 25484042›Full record

Trial reportmAbs2014

First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers.

Misty W Stevens, Ralph L Henry, S Michael Owens, Ralph Schutz, W Brooks Gentry

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in mAbs, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
3.9field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 47 citations in OpenAlex.

  1. Article
  2. An antifentanyl monoclonal antibody reverses fentanyl-induced apnea in pigs.The Journal of pharmacology and experimental therapeutics · 2025
    Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. In Vitro and In Vivo Sequestration of Phencyclidine by MeChemistry (Weinheim an der Bergstrasse, Germany) · 2021
    Article
  13. Review
  14. Monoclonal Antibodies Counteract Opioid-Induced Behavioral and Toxic Effects in Mice and Rats.The Journal of pharmacology and experimental therapeutics · 2020
    Article
  15. Article
  16. Review
  17. Monoclonal Antibodies for Combating Synthetic Opioid Intoxication.Journal of the American Chemical Society · 2019
    Article
  18. Effect of Bile Duct Ligation-induced Liver Dysfunction on Methamphetamine Pharmacokinetics and Locomotor Activity in Rats.Journal of pharmacy & pharmaceutical sciences : a publication of the Canadian Society for Pharmaceutical Sciences, Societe canadienne des sciences pharmaceutiques · 2019
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Misty W Stevensa InterveXion Therapeutics , LLC ; Little Rock , AR USA.
Ralph L Henry
S Michael Owens
Ralph Schutz
W Brooks Gentry
Arkansas Department of Agriculture · USFayetteville Public Library · USIQVIA (United Kingdom) · GBUniversity of Arkansas for Medical Sciences · US

Funding

Arkansas Center for Clinical and Translational ResearchUL1TR000039 · NCATS · UNIV OF ARKANSAS FOR MED SCIS · PI BECK, CORNELIA MARIE, JAMES, LAURA P · 2012 to 2014
$10.0M
First Human Studies of a Chimeric Anti-Methamphetamine Monoclonal AntibodyR01DA031944 · NIDA · UNIV OF ARKANSAS FOR MED SCIS · PI GENTRY, W BROOKS · 2011 to 2014
$3.1M
NCATS NIH HHS UL1 TR000039NCATS NIH HHS UL1TR000039NIDA NIH HHS R01 DA031944NIDA NIH HHS R01DA031944
6 · The paper itself

Abstract

This first-in-human study examined the safety and pharmacokinetics of ch-mAb7F9, an anti-methamphetamine monoclonal antibody, in healthy volunteers. Single, escalating doses of ch-mAb7F9 over the range of 0.2 to 20 mg/kg were administered to 42 subjects who were followed for 147 d. Safety was measured by physical examinations, adverse events, vital signs, electrocardiograms, and clinical laboratory testing. Serum ch-mAb7F9 concentration and immunogenicity analyses were performed. There were no serious adverse reactions or discontinuations from the study due to adverse events. No trends emerged in the frequency, relatedness, or severity of adverse events with increased dose or between active and placebo treated subjects. Ch-mAb7F9 displayed expected IgG pharmacokinetic parameters, including a half-life of 17-19 d in the 3 highest dose groups and volume of distribution of 5-6 L, suggesting the antibody is confined primarily to the vascular compartment. Four (12.5%) of the 32 subjects receiving ch-mAb7F9 were confirmed to have developed a human anti-chimeric antibody response by the end of the study; however, this response did not appear to be dose related. Overall, no apparent safety or tolerability concerns were identified; a maximum tolerated dose was not reached in this Phase 1 study. Ch-mAb7F9 therefore appears safe for human administration.

Indexed as

Healthy VolunteersAdolescentAdultAmphetamine-Related DisordersAntibodies, MonoclonalAntibody FormationArea Under CurveDose-Response Relationship, DrugFemaleHalf-LifeHumansMaleMetabolic Clearance RateMethamphetamineMiddle AgedRecombinant Fusion ProteinsAntibodies, MonoclonalMethamphetamineRecombinant Fusion ProteinsaddictionAE, adverse eventAUC(0-inf), area under the concentration-time curve from 0 to infinitychimeric antibodyCL, clearanceCmax, maximum concentrationCTCAE, Common Terminology Criteria for Adverse EventsECG, electrocardiogramFDA, Food and Drug Administrationfirst in humanGLP, good laboratory practiceHACA, human anti-chimeric antibodieshealthy volunteersKD, dissociation constantmAb, monoclonal antibodymethamphetamineMETH, (+)methamphetaminemonoclonal antibodypharmacokineticst1/2, apparent terminal half-lifeVd, volume of distribution

Identifiers

PMID25484042
PMCPMC4623385
OpenAlexW2046684621

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.