Trial reportmAbs2016
Serum pharmacokinetics and cerebrospinal fluid concentration analysis of the new IgG4 monoclonal antibody GNbAC1 to treat multiple sclerosis: A Phase 1 study.
Trial report in mAbs, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.
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
14 citing papers in PubMed, 22 citations in OpenAlex.
- HERVs Endophenotype in Autism Spectrum Disorder: Human Endogenous Retroviruses, Specific Immunoreactivity, and Disease Association in Different Family Members.Microorganisms · 2024Review
- Translational physiologically-based pharmacokinetic model for ocular disposition of monoclonal antibodies.Journal of pharmacokinetics and pharmacodynamics · 2024Article
- Distribution of Bevacizumab into the Cerebrospinal Fluid of Children and Adolescents with Recurrent Brain Tumors.Paediatric drugs · 2024Article
- Safety, Tolerability, and Pharmacokinetics of Zagotenemab in Participants with Symptomatic Alzheimer's Disease: A Phase I Clinical Trial.Journal of Alzheimer's disease reports · 2023Article
- Human Endogenous Retrovirus as Therapeutic Targets in Neurologic Disease.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Endogenous Retroviruses in Nervous System Disorders.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Crosstalk of Microorganisms and Immune Responses in Autoimmune Neuroinflammation: A Focus on Regulatory T Cells.Frontiers in immunology · 2021Review
- Temelimab, an IgG4 Anti-Human Endogenous Retrovirus Monoclonal Antibody: An Early Development Safety Review.Drug safety · 2020Article
- A translational platform PBPK model for antibody disposition in the brain.Journal of pharmacokinetics and pharmacodynamics · 2019Article
- The monoclonal antibody GNbAC1: targeting human endogenous retroviruses in multiple sclerosis.Therapeutic advances in neurological disorders · 2019Review
- Human Endogenous Retroviruses in Neurological Diseases.Trends in molecular medicine · 2018Review
- Immunoglobulin G; structure and functional implications of different subclass modifications in initiation and resolution of allergy.Immunity, inflammation and disease · 2018Review
- Central pharmacodynamic activity of solanezumab in mild Alzheimer's disease dementia.Alzheimer's & dementia (New York, N. Y.) · 2018Article
- HERV Envelope Proteins: Physiological Role and Pathogenic Potential in Cancer and Autoimmunity.Frontiers in microbiology · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
GNbAC1 is a humanized IgG4 monoclonal antibody antagonist of Mulitple Sclerosis Retrovirus Envelope (MSRV-Env), a protein that could play a critical role in multiple sclerosis. This randomized placebo-controlled dose-escalation study evaluated the safety and pharmacokinetics of GNbAC1 in 21 healthy volunteers after single intravenous infusion at doses of 6, 18 and 36 mg/kg. Lumbar punctures were performed at days 2, 15 or 29 to measure GNbAC1 concentrations in cerebrospinal fluid (CSF). GNbAC1 was well tolerated. Serum data show a dose-linear pharmacokinetics. A mean CSF/serum ratio of 0.12% was observed at Day 2, increasing to 0.39% at Day 15 and 0.42% at Day 29. Linear regression analysis shows a relationship between GNbAC1 CSF/serum ratio and albumin CSF/serum ratio and a relationship at the limit of statistical significance with the timing of CSF sampling.
Indexed as
Identifiers
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.