ArticleAuto- immunity highlights2019
Preclinical studies on the toxicology, pharmacokinetics and safety of K1-70
Article in Auto- immunity highlights, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 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.
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Who cites it
10 citing papers in PubMed, 15 citations in OpenAlex.
- Autoantibodies to the TSH Receptor-from discovery to understanding the mechanisms of action and to new therapeutics.Endocrine journal · 2025Review
- The evolving therapeutic landscape of Graves' disease in adults: present and future.European thyroid journal · 2025Review
- Review
- Zirconium- 89 Labeled Antibody K1-70 for PET Imaging of Thyroid-stimulating Hormone Receptor Expression in Thyroid Cancer.Molecular imaging and biology · 2024Article
- Characterizing the Interplay of Lymphocytes in Graves' Disease.International journal of molecular sciences · 2023Review
- Structure of full-length TSH receptor in complex with antibody K1-70™.Journal of molecular endocrinology · 2023Article
- Future Projections in Thyroid Eye Disease.The Journal of clinical endocrinology and metabolism · 2022Review
- Understanding Pathogenesis Intersects With Effective Treatment for Thyroid Eye Disease.The Journal of clinical endocrinology and metabolism · 2022Article
- TSH receptor specific monoclonal autoantibody K1-70Clinical endocrinology · 2022Article
- Targeting TSH and IGF-1 Receptors to Treat Thyroid Eye Disease.European thyroid journal · 2020Article
Corrections and comments
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Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe human monoclonal autoantibody K1-70™ binds to the TSH receptor (TSHR) with high affinity and blocks TSHR cyclic AMP stimulation by TSH and thyroid stimulating autoantibodies.
methodsThe preclinical toxicology assessment following weekly intravenous (IV) or intramuscular (IM) administration of K1-70™ in rats and cynomolgus monkeys for 29 days was carried out. An assessment of delayed onset toxicity and/or reversibility of toxicity was made during a further 4 week treatment free period. The pharmacokinetic parameters of K1-70™ and the effects of different doses of K1-70™ on serum thyroid hormone levels in the study animals were determined in rats and primates after IV and IM administration.
resultsLow serum levels of T3 and T4 associated with markedly elevated levels of TSH were observed in the study animals following IV and IM administration of K1-70™. The toxicological findings were attributed to the pharmacology of K1-70™ and were consistent with the hypothyroid state. The no observable adverse effect level (NOAEL) could not be established in the rat study while in the primate study it was 100 mg/kg/dose for both males and females.
conclusionsThe toxicology, pharmacodynamic and pharmacokinetic data in this preclinical study were helpful in designing the first in human study with K1-70™ administered to subjects with Graves' disease.
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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.