Evidence map›Paper›PMID 39736101›Full record

Trial reportClinical and translational science2025

A phase I, randomized, placebo-controlled trial to evaluate the pharmacokinetics, safety, and tolerability of nirsevimab in healthy Chinese adults.

Xiaomeng Mao, Xiaohan Hua, Chengyi Wu, Xiaoyun Ge, Jie Zhang, Xiaojie Wu, Robert J Kubiak, Ulrika Wählby Hamrén, Tonya Villafana, Georgios Christou and 3 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Clinical and translational science, 2025. 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. Trial
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

13 authors.

Xiaomeng MaoClinical Pharmacology Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Xiaohan HuaClinical Development, Respiratory & Immunology, R&D China, AstraZeneca, Shanghai, China.
Chengyi WuBiometrics, R&D China, AstraZeneca, Shanghai, China.
Xiaoyun GeClinical Safety, R&D China, AstraZeneca, Shanghai, China.ORCID 0009-0004-0533-3696
Jie ZhangDevelopment Operations, R&D China, AstraZeneca, Shanghai, China.
Xiaojie WuClinical Pharmacology Research Center, Huashan Hospital, Fudan University, Shanghai, China.
Robert J KubiakClinical Pharmacology and Quantitative Pharmacology, R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Ulrika Wählby HamrénClinical Pharmacology and Quantitative Pharmacology, R&D, AstraZeneca, Gothenburg, Sweden.ORCID 0000-0002-9761-9699
Tonya VillafanaClinical Development, Vaccines and Immune Therapies, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Georgios ChristouPatient Safety, Chief Medical Office, R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Jannine GreenGlobal Clinical Operations, R&D, AstraZeneca, Macclesfield, UK.
Therese TakasClinical Development, Vaccines and Immune Therapies, Biopharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Yuwen JinClinical Pharmacology, R&D China, AstraZeneca, Shanghai, China.ORCID 0009-0003-0977-6921

Funding

AstraZenecaSanofi
6 · The paper itself

Abstract

Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection (LRTI) in infants worldwide. Nirsevimab, an extended half-life monoclonal antibody against RSV, is approved in China for the prevention of RSV lower respiratory tract disease in infants; however, global nirsevimab trials did not enroll Chinese infants. To inform the investigation of nirsevimab for the prevention of RSV LRTI in Chinese infants, this Phase I, randomized, placebo-controlled trial evaluated the pharmacokinetics (PK) and safety of nirsevimab in healthy Chinese adults. Participants were randomized 3:1 to a single 300 mg intramuscular dose of nirsevimab or placebo and were followed through 150 days post-dose. Serum nirsevimab concentrations were measured and PK parameters of maximum serum concentration (C

Indexed as

Antibodies, Monoclonal, HumanizedHealthy VolunteersAdultAntiviral AgentsChinaDouble-Blind MethodEast Asian PeopleFemaleHumansInjections, IntramuscularMaleMiddle AgedRespiratory Syncytial Virus InfectionsYoung AdultAntibodies, Monoclonal, HumanizedAntiviral Agents

Identifiers

PMID39736101
PMCPMC11684469

What OpenQuestion holds

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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.