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SAFETY, PHARMACOKINETICS, AND CLINICAL EFFICACY OF ADS051, A NEUTROPHIL MODULATOR, IN ULCERATIVE COLITIS: RESULTS OF A RANDOMIZED PHASE 1B TRIAL.
Am J Gastroenterol
December 2024
Adiso Therapeutics, Inc, Concord, Massachusetts, USA.
Objectives: Ulcerative colitis (UC) is characterized by colonic inflammation, with neutrophils playing a key role in UC activity, prognosis, and response to therapies. Current UC therapeutics can have significant side effects and limited efficacy. ADS051 is a novel, oral, gut-restricted small molecule that modulates neutrophil migration and activation without in vitro suppression of T-cell activation.
View Article and Find Full Text PDFFast and accurate prediction of drug induced proarrhythmic risk with sex specific cardiac emulators.
NPJ Digit Med
December 2024
ELEM Biotech S.L., Pier 07, Via Laietana, 26, Barcelona, 08003, Spain.
In silico trials for drug safety assessment require many high-fidelity 3D cardiac simulations to predict drug-induced QT interval prolongation, which is often computationally prohibitive. To streamline this process, we developed sex-specific emulators for a fast prediction of QT interval, trained on a dataset of 900 simulations. Our results show significant differences between 3D and 0D single-cell models as risk levels increase, underscoring the ability of 3D modeling to capture more complex cardiac responses.
View Article and Find Full Text PDFOutcomes of Del Nido and hyperkalemic blood cardioplegia in adult cardiac surgery with prolonged aortic cross-clamp times★.
J Extra Corpor Technol
December 2024
College of Medicine and Public Health, Flinders University - Quality and Outcomes Unit, Cardiothoracic Surgical Unit, Division of Surgery, Flinders Medical Centre, Adelaide, South Australia, Australia.
Background: The utility and uptake of Del Nido cardioplegia in adult cardiac surgery is rapidly increasing. Cases with prolonged aortic cross-clamp times necessitate multi-dosing however an understanding of safe ischaemic times and definitive guidelines in this domain are lacking. Therefore, this study aimed to assess the safety and efficacy of our DNC strategy by comparing post-operative troponin profiles and clinical outcomes between Del Nido and hyperkalaemic cardioplegia for cases with aortic cross-clamp times of greater than 90 min.
View Article and Find Full Text PDFSafety, Pharmacokinetics and Antiviral Efficacy of Capsid Assembly Modulator Freethiadine in Healthy Volunteers and Chronic Hepatitis B Patients.
Liver Int
January 2025
Phase I Clinical Trial Center, the First Hospital of Jilin University, Jilin, China.
Background And Aims: Freethiadine is a novel hepatitis B virus capsid assembly modulator. Herein, we report the safety, tolerability, pharmacokinetics and 28-day antiviral activities of freethiadine.
Methods: The study consisted of two parts.
The Safety, Tolerability, and Pharmacokinetics of Active Ingredients From Hydroxysafflor Yellow A in Healthy Chinese Volunteers.
Clin Pharmacol Drug Dev
January 2025
The Second Clinical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
Hydroxysafflor yellow A (HSYA), an active ingredient extracted from Carthami flos, shows potential for treating ischemic stroke. This phase 1 study assessed the safety, tolerability, and pharmacokinetic (PK) properties of HSYA in healthy Chinese volunteers who received intravenous infusions of pure HSYA powder. The study comprised 2 parts.
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