Evidence map›Paper›PMID 34215019›Full record

ArticleDrug testing and analysis2021

Pharmacokinetic profiles of a SARS-COV-2 neutralizing antibody BD-604 in cynomolgus monkeys.

Feng Gao, Xu Zhang

Abstract read
In one paragraph

Article in Drug testing and analysis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. 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

2 authors.

Feng GaoSinglomics (Beijing DanXu Biopharmaceuticals) Co., Ltd., Beijing, China.ORCID https://orcid.org/0000-0001-8688-5126
Xu ZhangSinglomics (Beijing DanXu Biopharmaceuticals) Co., Ltd., Beijing, China.

Funding

Beijing Municipal Science and Technology Project Z201100007920018
6 · The paper itself

Abstract

backgroundCurrently, severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) has spread worldwide as a severe pandemic and effective therapeutic medications are urgently needed. As reported previously, BD-604 is a fully human monoclonal antibody with strong in vitro and in vivo neutralizing activity to SARS-COV-2.

objectiveThe purpose of this study was to characterize the pharmacokinetic propertie of BD-604 in cynomolgus monkeys.

methodsTo analyze the concentration of BD-604 in cynomolgus monkey serum, an ELISA assay was established, and a systemic validation was performed including accuracy and precision, dilution linearity and hook effect, selectivity, specificity, stability, and parallelism tests. Then, six naïve cynomolgus monkeys (3/sex) were administered BD-604 at a single dose of 10 mg/kg via intravenous infusion (60 min). Blood samples were collected at various time points (0-672 h) and analyzed for serum concentrations of BD-604.

resultsThe data from validation experiments assure the reproducibility and reliability of the established ELISA assay. Then, the validated method was used to measure BD-604 concentration in cynomolgus monkey serum. The pharmacokinetics parameters including terminal half-life (t

conclusionIn cynomolgus monkeys, BD-604 possesses pharmacokinetic properties similar to natural IgGs.

Indexed as

AnimalsAntibodies, MonoclonalAntibodies, NeutralizingCHO CellsCOVID-19CricetinaeCricetulusDose-Response Relationship, DrugFemaleHumansInfusions, IntravenousMacaca fascicularisMaleSARS-CoV-2Antibodies, MonoclonalAntibodies, NeutralizingBD-604monkeymonoclonal antibodypharmacokineticsSARS-COV-2

Identifiers

PMID34215019
PMCPMC8427073

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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.