Evidence map›Paper›PMID 41589687›Full record

ArticleClinical pharmacology and therapeutics2026

Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants.

Ziheng Hu, Farina Hellmann, Xiaowei Zang, Nele Plock, Keyur Parmar, Radha A Railkar, S Y Amy Cheung, Brian M Maas, Ferdous Gheyas

Abstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2026. 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. Review
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

9 authors.

Ziheng Hu *Merck & Co., Inc., Rahway, New Jersey, USA.
Farina Hellmann *Certara, Radnor, Pennsylvania, USA.
Xiaowei ZangMerck & Co., Inc., Rahway, New Jersey, USA.ORCID 0000-0002-8319-5303
Nele PlockCertara, Radnor, Pennsylvania, USA.
Keyur ParmarMerck & Co., Inc., Rahway, New Jersey, USA.
Radha A RailkarMerck & Co., Inc., Rahway, New Jersey, USA.
S Y Amy CheungCertara, Radnor, Pennsylvania, USA.ORCID 0000-0001-5138-7688
Brian M MaasMerck & Co., Inc., Rahway, New Jersey, USA.ORCID 0000-0002-2410-4379
Ferdous GheyasMerck & Co., Inc., Rahway, New Jersey, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Clesrovimab is a half-life extended monoclonal antibody targeting the respiratory syncytial virus fusion protein. Three studies (phase Ib/IIa [MK-1654-002], phase IIb/III [CLEVER], and phase III [SMART]) were conducted to evaluate the efficacy, safety, and pharmacokinetics (PK) of clesrovimab in infants. The objectives of this analysis were to develop an infant population PK model for clesrovimab and to evaluate the influence of intrinsic and extrinsic factors on clesrovimab PK in infants. A total of 5850 samples from 2942 participants were included in the population PK analysis. A two-compartment model with first-order absorption and elimination well described clesrovimab PK in infants. The estimated half-life for clesrovimab was 44.0 days. Clearance, absorption rate constant, and central volume of distribution had low inter-individual variability. Body weight was included as a covariate on all clearance and volume parameters, with estimated allometric scaling exponents centered on a body weight of 5 kg. A maturation function further described the change in clearance with increasing infant age. In addition to body weight and maturation function, the final model contained an effect of race on clearance. Although body weight, age, and race were identified as statistically significant covariates, the magnitude of the effect of these covariates on clesrovimab exposures was small (< 30%). The results of the population PK modeling support intramuscular administration of clesrovimab for the prevention of respiratory syncytial virus (RSV) disease in all infants, including healthy infants and infants at increased risk for severe RSV disease.

Indexed as

Antibodies, Monoclonal, HumanizedAntiviral AgentsInfant, PrematureModels, BiologicalRespiratory Syncytial Virus InfectionsAntibodies, MonoclonalFemaleHalf-LifeHumansInfantInfant, NewbornMaleViral Fusion ProteinsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntiviral AgentsclesrovimabViral Fusion Proteins

Identifiers

PMID41589687
PMCPMC12997513

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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.