101 results
The purpose of this study is to investigate how safe the new compound BMS-986224 is when it is administered as a single dose to healthy subjects and patients with chronic hart failure. It will also be investigated how quickly and to what extent BMS-…
The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…
The purpose of this study is to evaluate the effectiveness of the BMS-986259 study drug on blood pressure events in stable participants diagnosed with heart failure admitted to the hospital with Acute Decompensated Heart Failure (ADHF).
The primary objective of this study is to assess the efficacy of MEDI4736 treatment compared with placebo in terms of overall survival (OS) and progression free survival (PFS; (per RECIST 1.1 as assessed by the investigator).
In this study we will investigate biomarkers in blood after exposure to heparin in the fasted state or after a high-fat meal. Biomarkers are proteins present in the blood. The biomarkers investigated in this study are proteins that are involved in…
Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…
The study includes 2 periods, Period 1 and Period 2. Subjects will participate in both periods. Period 1:The purpose of Period 1 is to investigate how quickly and to what extent enpatoran is absorbed, transported and eliminated from the body (this…
The purpose of Part 1 is to investigate the effect of multiple doses of IMB-1018972 on the absorption, distribution and elimination of single doses of repaglinide and metformin and thereby understand to what extent IMB-1018972 may possibly change…
The purpose of this study is to investigate how quickly and to what extent the new compound BMS-986165 is absorbed and eliminated from the body (this is called pharmacokinetics) when it is administered to healthy volunteers without and with…
The study will be performed in 2 parts, Part 1 and Part 2). The purpose of the study is to investigate how quickly and to what extent Olesoxime is absorbed and eliminated from the body. In addition, it will be investigated how safe Olesoxime is and…
OBJECTIVES of the Study:Primary ObjectiveTo evaluate if the addition of ibrutinib to R-CHOP prolongs event-free survival (EFS) compared withR-CHOP alone in subjects with newly diagnosed non-GCB DLBCL.Secondary ObjectivesTo compare ibrutinib in…
To evaluate the safety, including tolerability, of ISIS 681257 and to assess the efficacy of different doses and dosing regimens of ISIS 681257 for reduction of plasma Lp(a) levels in patients with hyperlipoproteinemia(a) and established CVD.To…
1. To assess safety of different doses of a single iv injection of SGM-1012. To assess the performance of SGM-101 in the intraoperative detection of colorectal or pancreas cancer by:a. Tumor-to-background ratio (TBR);b. Concordance between…
The primary objective of the study is to evaluate a dose-response signal of IFX-1 in subjects with HS according to the HiSCR at Week 16. The secondary objectives of the study are:* To assess the efficacy of IFX-1 using additional outcome measures*…
The purpose of Part A of the study is to investigate to what extent VX-150 is tolerated when administered as a single dose (capsule). The effect of taking the dose with food and milk on how quickly and to what extent VX-150 is absorbed, distributed…
To assess the safety and tolerability and to define the dose limiting toxicities (DLT) and maximum tolerated dose (MTD) of BMS-986158 as for subjects with selected advanced solid tumors.
The primary objective of the study is To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF.The secondary objectives of the study are:* To evaluate the efficacy of BG00011 compared with placebo in subjects with IPF as…
The purpose of this study is to investigate the safety and tolerability of different doses of neosaxitoxin when it is administered to healthy male volunteers alone and in combination with bupivacaine (with and without epinephrine) in perineural…
The purpose of this study is to investigate how safe the new compound BMS-986278 is when it is administered as a single dose to healthy subjects. BMS-986278 has not been administered to humans before. It has been previously tested in the laboratory…
To investigate the safety, tolerability and efficacy of STR-324 infusions in healthy subjects.Primary objective (Parts 1 and 2)* To assess and characterise the safety and the tolerability of STR-324, over a 4-hour (Part 1) and a 48-h infusion (Part…