Evidence map›Paper›PMID 24080653›Full record

Trial reportAntimicrobial agents and chemotherapy2013

A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults.

Gabriel J Robbie, Ryan Criste, William F Dall'acqua, Kathryn Jensen, Nita K Patel, Genevieve A Losonsky, M Pamela Griffin

2 registry-linked trialsAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 191 papers.

0numbers the graph read from it
0cells of the map it votes in
191citing papers in PubMed
–field-weighted citation impact
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.

NCT00578682 phase1completednot on this map

A Phase I, Randomized, Double-Blind, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557, A Humanized Monoclonal Antibody With an Extended Half-Life Against Respiratory Syncytial Virus (RSV), in Healthy Adults

TypeinterventionalSponsorMedImmune LLCRan2007 to 2010Enrolled31ConditionsHealthyArmsMEDI-557
NCT04625725 phase3completednot on this mapstarted 2020, after this paper: background citation

A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19.

TypeinterventionalSponsorAstraZenecaRan2020 to 2023Enrolled5,197ConditionsCOVID-19ArmsAZD7442, Placebo
3 · Its place in the literature

Who cites it

191 citing papers in PubMed.

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131 more citing papers are in PubMed but not listed here.

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

7 authors.

Gabriel J RobbieClinical Pharmacology and DMPK.
Ryan Criste
William F Dall'acqua
Kathryn Jensen
Nita K Patel
Genevieve A Losonsky
M Pamela Griffin

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The study objective was to evaluate the pharmacokinetics (PK), antidrug antibody (ADA), and safety of motavizumab-YTE (motavizumab with amino acid substitutions M252Y/S254T/T256E [YTE]), an Fc-modified anti-respiratory syncytial virus (RSV) monoclonal antibody. Healthy adults (n = 31) were randomized to receive a single intravenous (i.v.) dose of motavizumab-YTE or motavizumab (0.3, 3, 15, or 30 mg/kg) and followed for 240 days. Clearance of motavizumab-YTE was significantly lower (71% to 86%) and the half-life (t1/2) was 2- to 4-fold longer than with motavizumab. However, similar peak concentrations and volume-of-distribution values, indicative of similar distribution properties, were seen at all dose levels. The sustained serum concentrations of motavizumab-YTE were fully functional, as shown by RSV neutralizing activity that persisted for 240 days with motavizumab-YTE versus 90 days postdose for motavizumab. Safety and incidence of ADA were comparable between groups. In this first study of an Fc-modified monoclonal antibody in humans, motavizumab-YTE was well tolerated and exhibited an extended half-life of up to 100 days. (This study has been registered at ClinicalTrials.gov under registration no. NCT00578682.).

Indexed as

AdultAntibodies, Monoclonal, HumanizedAntiviral AgentsDouble-Blind MethodDrugs, InvestigationalFemaleHalf-LifeHumansImmunoglobulin Fc FragmentsInjections, IntravenousMaleMetabolic Clearance RateAntibodies, Monoclonal, HumanizedAntiviral AgentsDrugs, InvestigationalImmunoglobulin Fc Fragmentsmotavizumab

Identifiers

PMID24080653
PMCPMC3837853

What OpenQuestion holds

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Registered trials

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.