11 results
To evaluate the safety and tolerability of multiple escalating doses of intravenous WCK 4282 in healthy, adult, human subjects.To evaluate the pharmacokinetics (PK) of multiple escalating doses of 1g:1g (1 vial) of intravenous (IV) WCK 4282 every 8…
1. Overall survival (primary efficacy endpoint)2a. Efficacy: progression-free survival (PFS), overall response rate (ORR = CR + PR), and a clincal benefit rate (CBR) will be evaluated as CR + PR + SD for at least 3 months.2b. Safety: adverse events…
The purpose of the study is to investigate how safe the compound USL260 is and how well the compound USL260 is tolerated under fasting and fed conditions. The study will also investigate how quickly and to what extent the compound USL260 is absorbed…
The purpose of the study is to determine how a single administration of rifampicin influences the uptake and breakdown of clazosentan. Furthermore, the safety and tolerability of clazosentan when administered after administration of rifampicin, will…
The aim of this study is to determine the effects of propranolol on patients* crucial fear-related memories and dental trait anxiety in those undergoing surgical removal of one of their teeth or molars. The hypotheses that are tested are that…
• To demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care based on the clinical severity status in adult hospitalized patients with COVID-19• To show that ATR-002 in addition to standard of care shortens the time to…
Primary Efficacy ObjectivesUnless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + paclitaxel + bevacizumab (Arm B) versus carboplatin + paclitaxel + bevacizumab (…
Unless otherwise specified, efficacy objectives will be analyzed for the following two treatment comparisons:• Atezolizumab + carboplatin + nab-paclitaxel (Arm B) versus carboplatin + nab- paclitaxel (Arm C)• Atezolizumab + carboplatin + paclitaxel…
Primary- To investigate the safety and tolerability of JNJ-55363932 after single oral dose administration(ascending dose levels) in healthy participants- To characterize the PK of JNJ-55363932 in plasma, cerebrospinal fluid (CSF) and urine…
To characterize the single-dose pharmacokinetic (PK) of RPV after SC administration of RPV LA suspensions with different doses and/or different particle size (PS) to support further dose and formulation selection, in healthy adult participants.To…
Primary• To assess the safety and tolerability in healthy volunteers of nizaracianine administered IV in three divided dosesSecondary• To perform pharmacokinetic analyses of blood and urine• To determine if bolus injection of nizaracianine enables…