ReviewBritish journal of clinical pharmacology2013
Giving monoclonal antibodies to healthy volunteers in phase 1 trials: is it safe?
Review in British journal of clinical pharmacology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled 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.
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
11 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Who should be included in first-in-human trials? A systematic review of reasons.Journal of translational medicine · 2025Pooled it
- Pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a new biosimilar medicine of adalimumab/Humira, in healthy subjects.British journal of clinical pharmacology · 2017Trial
- Article
- Highlights into the pharmacology of nutraceuticals.British journal of pharmacology · 2020Article
- Nanoparticle-Induced Complement Activation: Implications for Cancer Nanomedicine.Frontiers in immunology · 2020Review
- Humanized Mouse as a Tool to Predict Immunotoxicity of Human Biologics.Frontiers in immunology · 2020Article
- Inverse pharmacology: Approaches and tools for introducing druggability into engineered proteins.Biotechnology advances · 2019Review
- Safety Profile of Anticancer and Immune-Modulating Biotech Drugs Used in a Real World Setting in Campania Region (Italy): BIO-Cam Observational Study.Frontiers in pharmacology · 2017Article
- Is there a role of synovial biopsy in drug development?BMC musculoskeletal disorders · 2016Review
- Pre-clinical immunotoxicity studies of nanotechnology-formulated drugs: Challenges, considerations and strategy.Journal of controlled release : official journal of the Controlled Release Society · 2015Review
- Biological therapies: a long way on from Jenner.British journal of clinical pharmacology · 2013Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Many monoclonal antibodies (MAbs) have been studied in healthy volunteers in phase 1, but few data have been published on the safety of that practice. We aimed to review the available data, and thereby to estimate the risks of participation in phase 1trials of MAbs. We searched PubMed, the ClinicalTrials.gov database and Google, using the search terms 'monoclonal antibody', 'phase 1' and 'healthy volunteers'. We identified 70 completed trials of MAbs in healthy volunteers, but the published data were too sparse to allow confident assessment of the risks of MAbs in healthy volunteers. Our best estimate of risk of a life-threatening adverse event was between 1: 425 and 1: 1700 volunteer-trials, but all such events occurred in a single trial (of TGN1412). In a phase 1trial of a small molecule, the risk of death or a life-threatening adverse event appears to be 1: 100,000-1,000,000 volunteer-trials, which is similar to the risk of many ordinary daily activities. Most people would consider that level of risk to be 'minimal' or 'negligible' and, therefore, acceptable. On that basis, the safety record of MAbs in healthy volunteers has been ruined by the TGN1412 disaster. However, that experience is unlikely to be repeated, because of improvements in governance and practice of phase 1trials. If the experience of TGN1412 is disregarded, it seems reasonable to continue using healthy volunteers in phase 1trials of MAbs, provided that there are scientific and medical reasons to conclude that the risk is truly minimal.
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What OpenQuestion holds
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.