Trial reportClinical and translational science2022
A phase I study to evaluate safety, pharmacokinetics, and pharmacodynamics of respiratory syncytial virus neutralizing monoclonal antibody MK-1654 in healthy Japanese adults.
Trial report in Clinical and translational science, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
What it found
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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.
Who cites it
12 citing papers in PubMed, 25 citations in OpenAlex.
- A Phase 1b/2a Trial of a Half-life Extended Respiratory Syncytial Virus Neutralizing Antibody, Clesrovimab, in Healthy Preterm and Full-term Infants.The Journal of infectious diseases · 2025Trial
- A phase I study to evaluate safety, pharmacokinetics, and pharmacodynamics of respiratory syncytial virus neutralizing monoclonal antibody MK-1654 in healthy Japanese adults.Clinical and translational science · 2022Trial
- Population Pharmacokinetics of Clesrovimab in Preterm and Full-Term Infants.Clinical pharmacology and therapeutics · 2026Article
- Preclinical characterisation of the protective capacity of an anti-nucleoprotein hRSV monoclonal antibody.EBioMedicine · 2026Article
- Phase I open-label study of the respiratory syncytial virus monoclonal antibody clesrovimab: Safety and tolerability in healthy Chinese participants.Human vaccines & immunotherapeutics · 2025Article
- Clesrovimab: First Approval.Drugs · 2025Review
- Prevention of respiratory syncytial virus disease across the lifespan in Italy.Pneumonia (Nathan Qld.) · 2025Review
- The recent landscape of RSV vaccine research.Therapeutic advances in vaccines and immunotherapy · 2025Review
- Vaccine and therapeutic agents against the respiratory syncytial virus: resolved and unresolved issue.MedComm · 2024Review
- Respiratory syncytial virus infection and novel interventions.Nature reviews. Microbiology · 2023Review
- The road to approved vaccines for respiratory syncytial virus.NPJ vaccines · 2023Review
- Clinical research on RSV prevention in children and pregnant women: progress and perspectives.Frontiers in immunology · 2023Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Respiratory syncytial virus (RSV) is the leading cause of lower respiratory tract infection among all infants worldwide and remains a significant cause of morbidity and mortality. To address this unmet medical need, MK-1654, a half-life extended RSV neutralizing monoclonal antibody, is in clinical development for the prevention of RSV disease in infants. This was a phase I, randomized, placebo-controlled, single-site, double-blind trial of MK-1654 in 44 healthy Japanese adults. The safety, tolerability, pharmacokinetics, antidrug antibodies (ADAs), and serum neutralizing antibody (SNA) titers against RSV were evaluated for 1 year after a single intramuscular (i.m.) or intravenous (i.v.) dose of MK-1654 or placebo in five groups (100 mg i.m., 300 mg i.m., 300 mg i.v., 1000 mg i.v., or placebo). MK-1654 was generally well-tolerated in Japanese adults. There were no serious drug-related adverse events (AEs) reported in any MK-1654 recipient and no discontinuations due to any AEs in the study. The half-life of MK-1654 ranged from 76 to 91 days across dosing groups. Estimated bioavailability was 86% for 100 mg i.m. and 77% for 300 mg i.m. One participant out of 33 (3.0%) developed detectable ADA with no apparent associated AEs. The RSV SNA titers increased in a dose-dependent manner among participants who received MK-1654. These data support the development of MK-1654 for use in Japanese infants.
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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.