Pharmacokinetics and pharmacodynamics of Abelacimab (MAA868), a novel dual inhibitor of Factor XI and Factor XIa
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Le résumé fourni par la source
BACKGROUND: Factor XI (FXI) inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of thromboembolic events. Abelacimab (MAA868) is a novel fully human monoclonal antibody that targets the catalytic domain and has dual activity against the inactive zymogen Factor XI and the activated FXI. OBJECTIVES: To investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of single dose intravenous and multiple dose subcutaneous administration of abelacimab in healthy volunteers and patients with atrial fibrillation, respectively. PATIENTS/METHODS: In study ANT-003, healthy volunteers were administered single intravenous doses of abelacimab (30-150 mg) or placebo. The ANT-003 study also included a cohort of obese but otherwise healthy subjects. In study ANT-004, patients with atrial fibrillation were administered monthly subcutaneous doses of abelacimab (120 mg and 180 mg), or placebo, for 3 months. Key PK and PD parameters, including activated partial thromboplastin time (aPTT) and free FXI levels, as well as anti-drug antibodies (ADA) were assessed. RESULTS: Following intravenous administration of abelacimab, the terminal elimination half-life ranged from 25 to 30 days. One hour after the start of the intravenous infusion greater than 99% reductions in free FXI levels were observed. Following once monthly subcutaneous administration, marked reductions from baseline in free FXI levels were sustained. Parenteral administration of abelacimab demonstrated a favorable safety profile with no clinically relevant bleeding events. CONCLUSIONS: Intravenous and multiple subcutaneous dose administration of abelacimab were safe and well tolerated. The safety, PK, and PD data from these studies support the clinical development of abelacimab.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Pharmacokinetics and pharmacodynamics of Abelacimab (MAA868), a novel dual inhibitor of Factor XI and Factor XIa
- Date Crossref
- 01/02/2022
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
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Anthos Therapeutics (United States) pays non établi dans la noticeEntreprise
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Certara (United States) pays non établi dans la noticeEntreprise
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Integra LifeSciences (United States) pays non établi dans la noticeEntreprise
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Instrumental Polymer Technologies (United States) pays non établi dans la noticeEntreprise
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Covance (United Kingdom) pays non établi dans la noticeEntreprise
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Westside Medical Associates of Los Angeles pays non établi dans la noticeÉtablissement de santé
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Anthos Therapeutics Cambridge Massachusetts USA pays non établi dans la noticeInstitution
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Certara Princeton New Jersey USA pays non établi dans la noticeInstitution
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Apollo Biologics pays non établi dans la noticeInstitution
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Covance by LabCorp pays non établi dans la noticeInstitution
Anthos Therapeutics (United States), Certara (United States) et Integra LifeSciences (United States), avec 7 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.