Trial reportEuropean journal of clinical pharmacology2016
First-in-human study to assess guselkumab (anti-IL-23 mAb) pharmacokinetics/safety in healthy subjects and patients with moderate-to-severe psoriasis.
Trial report in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 6 of them syntheses that pooled it.
What it found
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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
33 citing papers in PubMed, 6 syntheses or guidelines pooled it, 82 citations in OpenAlex.
- Pharmacokinetics of IL-23p19 Inhibitors: A Systematic Review Across Immune-Mediated Inflammatory Diseases.Clinical pharmacokinetics · 2026Pooled it
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2022Pooled it
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2021Pooled it
- Adverse Events Associated With Anti-IL-23 Agents: Clinical Evidence and Possible Mechanisms.Frontiers in immunology · 2021Pooled it
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2020Pooled it
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2017Pooled it
- Efficacy and Safety of Guselkumab, an Interleukin-23p19-Specific Monoclonal Antibody, Through One Year in Biologic-Naive Patients With Psoriatic Arthritis.Arthritis & rheumatology (Hoboken, N.J.) · 2021Trial
- Trial
- Improvement in latent variable indirect response modeling of multiple categorical clinical endpoints: application to modeling of guselkumab treatment effects in psoriatic patients.Journal of pharmacokinetics and pharmacodynamics · 2017Trial
- Lack of Differences in the Pharmacokinetics of Therapeutic Monoclonal Antibodies Between Japanese and Non-Japanese Individuals.Journal of clinical pharmacology · 2026Review
- Positioning Guselkumab in The Treatment Algorithm for Ulcerative Colitis.Journal of inflammation research · 2026Review
- Guselkumab Reduces Disease- and Mechanism-Related Biomarkers More Than Adalimumab in Patients with Psoriasis: A VOYAGE 1 Substudy.JID innovations : skin science from molecules to population health · 2024Article
- Inter-Antibody Variability in the Clinical Pharmacokinetics of Monoclonal Antibodies Characterized Using Population Physiologically Based Pharmacokinetic Modeling.Antibodies (Basel, Switzerland) · 2024Article
- Review
- Pharmacokinetics and Safety of the Tyrosine Kinase 2 Inhibitor Deucravacitinib in Healthy Chinese Subjects.Dermatology and therapy · 2023Article
- Systemic pharmacological treatments for chronic plaque psoriasis: a network meta-analysis.The Cochrane database of systematic reviews · 2023Review
- Guselkumab More Effectively Neutralizes Psoriasis-Associated Histologic, Transcriptomic, and Clinical Measures than Ustekinumab.ImmunoHorizons · 2023Article
- Novel Biotherapeutics Targeting Biomolecular and Cellular Approaches in Diabetic Wound Healing.Biomedicines · 2023Review
- Estimation of Clearance and Bioavailability of Therapeutic Monoclonal Antibodies from Only Subcutaneous Injection Data in Humans Based on Comprehensive Analysis of Clinical Data.Clinical pharmacokinetics · 2021Article
- Vaccinations in Patients Receiving Systemic Drugs for Skin Disorders: What Can We Learn for SARS-Cov-2 Vaccination Strategies?Drugs in R&D · 2021Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe purpose of this study is to evaluate the pharmacokinetics, immunogenicity, safety, and tolerability of guselkumab, a human monoclonal antibody with high affinity and specificity for binding to interleukin-23.
methodsIn this first-in-human, phase 1, randomized study, a single intravenous (IV; 0.03-10 mg/kg) or subcutaneous (SC; 10-300 mg) dose of guselkumab was administered to 47 healthy subjects, and a single SC dose (placebo, 10, 30, 100, 300 mg) was administered to 24 patients with moderate-to-severe psoriasis.
resultsMean maximum observed serum concentration and area under the zero-to-infinity serum concentration-time curve of guselkumab increased in an approximately dose-proportional manner over the dose range of 0.03-10 mg/kg following a single IV administration or 10-300 mg following a single SC administration. Mean clearance and volume of distribution ranged from 3.62-6.03 mL/day/kg and 99.38-123.22 mL/kg, respectively. Mean half-life ranged from 12 to 19 days in healthy subjects and patients with psoriasis. Among guselkumab-treated subjects/patients, 1/30 (3.3 %) healthy subjects in the IV group, 0/6 healthy subjects in the SC group, and 1/20 (5.0 %) patients with psoriasis tested positive for antibodies to guselkumab. No clinically significant adverse events were identified in this study.
conclusionGuselkumab pharmacokinetic profiles were generally comparable between healthy subjects and patients with psoriasis. Guselkumab, administered as an IV infusion or SC injection, was well tolerated in healthy subjects and patients with psoriasis.
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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.