Clinical Research Directory

Phase 1a/b Tolerability of NTR-1011 in Healthy Adults and Adult Patients With SLE and RA

This phase 1a and 1b study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of NTR-1011 in healthy adults and in adult patients with systemic lupus erythematosus and rheumatoid arthritis. The main goals of this study are to determine the safety profile of NTR-1011 across subcutaneous and intravenous dose levels, understand how the drug behaves in the body, characterize its biological activity through relevant pharmacodynamic markers, assess the potential for immune responses to treatment, and explore early signals of clinical benefit in autoimmune disease settings. This is a randomized, double blind, placebo controlled study that begins with a single ascending dose evaluation in healthy volunteers followed by a multiple dose assessment in patients. The design is intended to define the highest safe and well tolerated dose, establish a robust PK and PD baseline, and generate initial patient level evidence to support dose selection and advancement into subsequent clinical development.

A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease

A subcutaneous formulation of infliximab CT-P13 (Remsima, Celltrion) has been approved for clinical use in inflammatory bowel disease (IBD) and rheumatoid arthritis (RA) after demonstration of pharmacokinetic (PK) non-inferiority compared to intravenous CT-P13. The added value of the subcutaneous formulation of CT-P13 has been recognized by IBD physician expert, patients and nurses. However, further investigation is needed to select the right patients and timing for switching to the new subcutaneous formulation. Before investing resources into the design and execution of a prospective clinical trial to address these remaining clinical questions and concerns, an in silica simulation study using a population pharmacokinetic-pharmacodynamic (popPK-PD) model of CT-P13 would be highly informative. While popPK models of subcutaneous infliximab CT-P13 have been developed for both IBD and RA, a popPK-PD model is still awaited. The development of a popPK-PD model would allow us to bridge infliximab exposure and response, and address clinically relevant questions by focussing on therapeutic outcomes.