{
  "abstract": "Objectives: SARS‐CoV‐2 infection remains a threat to vulnerable groups. Neutralising monoclonal antibodies (mAbs) have shown efficacy in the treatment and prevention of COVID‐19, but most mAbs have lost activity against recent Omicron strains.\n\nMethods: We previously isolated a receptor binding domain‐specific mAb from a COVID‐19 convalescent donor, PDI204, which retained activity against several early Omicron strains. This randomised, double‐blind, placebo‐controlled phase I clinical trial enrolled healthy adults (n = 32) to receive PDI204 intravenously (IV) at three different doses (200, 600, 1200 mg) or intramuscularly (IM) at 300 mg.\n\nResults: PDI204 was safe and tolerable with only Grade 1 and 2 adverse events. High serum levels of PDI204 were detected in PDI204‐dosed participants with a median elimination half‐life of 17.7 days (IQR 16.3–22.1). Boosted neutralising activity and Fc receptor binding were observed in serum against ancestral and Omicron BA.5 SARS‐CoV‐2 strains, but not against the later Omicron strain XBB.1.5. IM‐dosed subjects had peak PDI204 levels in serum 2–6 days later than IV‐dosed subjects. Entry of PDI204 into saliva from blood was low and variable, and primarily detected in participants receiving 600 mg or 1200 mg doses. Three of 32 people acquired COVID‐19 within 90 days of dosing, two receiving PDI204 and one in a placebo recipient.\n\nConclusion: Overall, the mAb PDI204 was safe but lost activity against later Omicron strains and did not prevent COVID‐19 during this trial.",
  "abstract_shown": true,
  "affiliations": [
    "Department of Microbiology and Immunology University of Melbourne, The Peter Doherty Institute for Infection and Immunity Melbourne VIC Australia",
    "Faculty of Medicine and Health, Sydney School of Public Health The University of Sydney Sydney NSW Australia",
    "Department of Infectious Diseases University of Melbourne, The Peter Doherty Institute for Infection and Immunity Melbourne VIC Australia",
    "Programme in Emerging Infectious Diseases Duke‐NUS Medical School Singapore Singapore",
    "Infectious Diseases Translational Research Program, Department of Microbiology and Immunology Yong Loo Lin School of Medicine, National University of Singapore Singapore Singapore",
    "National Centre for Infectious Diseases Singapore Singapore",
    "Nucleus Network Melbourne VIC Australia",
    "Department of Infectious Diseases The Alfred Hospital and School of Translational Medicine, Monash University Melbourne VIC Australia",
    "BioSensis Consulting Brisbane QLD Australia",
    "Biotherapeutics Program CSIRO Biosecurity Clayton VIC Australia",
    "Kirby Institute University of New South Wales Kensington NSW Australia",
    "National Biologics Facility, Australian Institute for Bioengineering and Nanotechnology The University of Queensland Brisbane QLD Australia",
    "Melbourne Sexual Health Centre and Department of Infectious Diseases Alfred Hospital and Central Clinical School, Monash University Melbourne VIC Australia"
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 26,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Wen Shi Lee",
      "orcid": "0000-0001-7285-4054"
    },
    {
      "affs": [
        0
      ],
      "name": "Kevin J Selva",
      "orcid": "0000-0002-0780-9422"
    },
    {
      "affs": [
        1
      ],
      "name": "Timothy E Schlub",
      "orcid": "0000-0001-7746-9649"
    },
    {
      "affs": [
        0,
        2
      ],
      "name": "Jennifer Audsley",
      "orcid": "0000-0001-6322-3197"
    },
    {
      "affs": [
        0
      ],
      "name": "Janavi S Rambhatla"
    },
    {
      "affs": [
        0
      ],
      "name": "Robyn Esterbauer",
      "orcid": "0000-0002-7091-0048"
    },
    {
      "affs": [
        0
      ],
      "name": "Jennifer A Juno",
      "orcid": "0000-0002-9072-1017"
    },
    {
      "affs": [
        0
      ],
      "name": "Andrew Kelly"
    },
    {
      "affs": [
        0
      ],
      "name": "Ellie Reilly"
    },
    {
      "affs": [
        0
      ],
      "name": "Thakshila Amarasena"
    },
    {
      "affs": [
        0
      ],
      "name": "Sarah Lee",
      "orcid": "0009-0003-8870-0975"
    },
    {
      "affs": [
        0
      ],
      "name": "Hyon‐Xhi Tan",
      "orcid": "0000-0003-1064-3934"
    },
    {
      "affs": [
        3,
        4
      ],
      "name": "Chee Wah Tan",
      "orcid": "0000-0001-9837-1413"
    },
    {
      "affs": [
        3,
        5
      ],
      "name": "Lin‐Fa Wang",
      "orcid": "0000-0003-2752-0535"
    },
    {
      "affs": [
        6,
        7
      ],
      "name": "Christina C Chang"
    },
    {
      "affs": [
        8
      ],
      "name": "Michael Gerometta"
    },
    {
      "affs": [
        9
      ],
      "name": "Judith A Scoble",
      "orcid": "0000-0002-6652-0717"
    },
    {
      "affs": [
        9
      ],
      "name": "Patrick F James",
      "orcid": "0000-0003-0301-6107"
    },
    {
      "affs": [
        10
      ],
      "name": "Arnold Reynaldi",
      "orcid": "0000-0002-5529-5542"
    },
    {
      "affs": [
        10
      ],
      "name": "Miles P Davenport",
      "orcid": "0000-0002-4751-1831"
    },
    {
      "affs": [
        11
      ],
      "name": "Kym Hoger",
      "orcid": "0009-0000-0089-0064"
    },
    {
      "affs": [
        11
      ],
      "name": "Karen Hughes"
    },
    {
      "affs": [
        11
      ],
      "name": "Martina L Jones",
      "orcid": "0000-0002-5154-6017"
    },
    {
      "affs": [
        11
      ],
      "name": "Ben Hughes",
      "orcid": "0009-0000-3289-2195"
    },
    {
      "affs": [
        0
      ],
      "name": "Adam K Wheatley",
      "orcid": "0000-0002-5593-9387"
    },
    {
      "affs": [
        0,
        12
      ],
      "name": "Stephen J Kent",
      "orcid": "0000-0002-8539-4891"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/82wtmv6g1264y.bib",
  "cited_by": 0,
  "doi": "10.1002/cti2.70126",
  "fulltext_url": "https://pmc.ncbi.nlm.nih.gov/articles/PMC13735506/",
  "id": "82wtmv6g1264y",
  "issns": [
    "2050-0068"
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  "landing_url": "https://doi.org/10.1002/cti2.70126",
  "language": "en",
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "heading",
      "Original Article"
    ],
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      "openalex",
      "2725|SARS-CoV-2 and COVID-19 Research"
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  "openalex": "W7225238474",
  "pdf_url": "https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cti2.70126",
  "pmcid": "PMC13735506",
  "pmid": "42990827",
  "published": "2026-11-04",
  "publisher": "Wiley",
  "ris": "https://research.draconitic.com/paper/82wtmv6g1264y.ris",
  "sources": [
    {
      "first_seen": "2026-11-09T12:21:10Z",
      "native_id": "PMC13735506",
      "source": "pmc",
      "url": "https://doi.org/10.1002/cti2.70126"
    }
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2725|SARS-CoV-2 and COVID-19 Research",
      "subfield": "infectious-disease"
    }
  ],
  "title": "Randomised controlled phase I trial of a SARS‐CoV‐2 monoclonal antibody",
  "title_text": "Randomised controlled phase I trial of a SARS‐CoV‐2 monoclonal antibody",
  "type": "peer-reviewed",
  "updated_at": "2026-11-09T12:21:10Z",
  "url": "https://research.draconitic.com/paper/82wtmv6g1264y",
  "venue": "Clinical & Translational Immunology",
  "versions": []
}