Trial reportEuropean journal of clinical pharmacology2018
Safety, pharmacokinetics and pharmacodynamics of single rising doses of BI 655064, an antagonistic anti-CD40 antibody in healthy subjects: a potential novel treatment for autoimmune diseases.
Trial report in European journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01510782 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses), which is not on this map. Cited by 19 papers.
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.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (0.2 mg to 120 mg Administered by Intravenous Infusion and 40 mg to 120 mg Administered by Subcutaneous Injection) of BI 655064 (Buffer Solution for Injection) in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
Who cites it
19 citing papers in PubMed, 33 citations in OpenAlex.
- Safety, pharmacokinetics and pharmacodynamics of BI 655064 in phase 1 clinical trials in healthy Chinese and Japanese subjects.British journal of clinical pharmacology · 2021Trial
- Effects of BI 655064, an antagonistic anti-CD40 antibody, on clinical and biomarker variables in patients with active rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase IIa study.Annals of the rheumatic diseases · 2019Trial
- Safety, Pharmacokinetics, and Pharmacodynamics of Multiple Rising Doses of BI 655064, an Antagonistic Anti-CD40 Antibody, in Healthy Subjects: A Potential Novel Treatment for Autoimmune Diseases.Journal of clinical pharmacology · 2018Trial
- Randomized, controlled study of bleselumab (ASKP1240) pharmacokinetics and safety in patients with moderate-to-severe plaque psoriasis.Biopharmaceutics & drug disposition · 2018Trial
- Targeting T follicular helper cells for lifelong health.Nature reviews. Drug discovery · 2026Review
- Clinical applications and challenges of CD40/CD40L signaling regulation in autoimmune diseases.Frontiers in immunology · 2026Review
- Implications of CD154 and Its Receptors in the Pathogenesis and Treatment of Systemic Lupus Erythematosus.Cells · 2024Review
- Intrafamily heterooligomerization as an emerging mechanism of methyltransferase regulation.Epigenetics & chromatin · 2024Review
- A CD40 variant is associated with systemic bone loss among patients with rheumatoid arthritis.Clinical rheumatology · 2022Article
- CD40-CD40L in Neurological Disease.International journal of molecular sciences · 2022Review
- Role of CD40(L)-TRAF signaling in inflammation and resolution-a double-edged sword.Frontiers in pharmacology · 2022Review
- Optimal Immunosuppression Strategy in the Sensitized Kidney Transplant Recipient.Journal of clinical medicine · 2021Review
- Molecular basis and therapeutic implications of CD40/CD40L immune checkpoint.Pharmacology & therapeutics · 2021Review
- Targeting B cells for inflammatory bowel disease treatment: back to the future.Current opinion in pharmacology · 2020Review
- CD40/CD40L and Related Signaling Pathways in Cardiovascular Health and Disease-The Pros and Cons for Cardioprotection.International journal of molecular sciences · 2020Review
- Recent advances in the development of protein-protein interactions modulators: mechanisms and clinical trials.Signal transduction and targeted therapy · 2020Review
- Protecting the kidney in systemic lupus erythematosus: from diagnosis to therapy.Nature reviews. Rheumatology · 2020Review
- Antithymocyte Globulin Antibody Titer Congruent With Kidney Transplantation: Analysis of Incidence, Outcomes, Cost, and Alternative Targets.Transplantation direct · 2019Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe CD40-CD40L pathway is a promising treatment target for autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus and lupus nephritis. The safety, pharmacokinetics and pharmacodynamics of BI 655064, a novel humanised antagonistic anti-CD40 monoclonal antibody, were investigated in this first-in-human trial.
methodsHealthy male subjects (n = 72) were randomised 3:1, within each BI 655064 dose group, to single intravenous (IV; 0.2-120 mg) or subcutaneous (SC; 40-120 mg) doses of BI 655064 or placebo. Safety, plasma exposure, CD40 receptor occupancy and CD40L-induced CD54 upregulation were assessed over 12 weeks.
resultsAdverse events (AEs) were reported in 43% of subjects (n = 31). Frequency and intensity of AEs were generally similar between BI 655064 and placebo and showed no dose relationship. The most frequent AEs were headache and nasopharyngitis. One mild rash and one local reaction occurred with SC BI 655064; two serious AEs were reported, both judged unrelated to BI 655064. Pharmacokinetic evaluation demonstrated a more than proportional increase in plasma exposure relative to BI 655064 dose, with a terminal half-life between 4 h and 4 days IV and approximately 5 days SC; doses ≥ 20 mg IV and 120 mg SC showed > 90% CD40 receptor occupancy and inhibition of CD54 upregulation, which lasted 7 days in the 120 mg IV and SC groups.
conclusionsSingle doses up to 120 mg BI 655064 IV and SC were well tolerated and showed a high potential to block the CD40-CD40L pathway, supporting further clinical development of BI 655064 in patients with autoimmune disease.
trial registrationClinicalTrials.gov Identifier: NCT01510782.
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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.