51 results
To determine the effect of benralizumab on the rate of asthma exacerbationsSubstudy: - To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen whilemaintaining asthma control.- To assess…
To assess the effect of treatment with 100 mg of FAB122 (edaravone) on disease progression in patients with ALS.
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of the study drug CT1812 in subjects with mild to moderate Alzheimer*s disease. The efficacy of CT1812 will be compared to the efficacy of a placebo. A placebo is a…
Primary ObjectivesParts 1 and 2: To evaluate the safety and tolerability, describe any dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) or highest protocol- defined doses (in the absence of exceeding the MTD) and the…
The objective of the trial is to assess the long-term safety and tolerability of intracerebroventricular administration of sNN0029 infusion solution at a dose of 4 µg/day delivered via a Medtronic SynchroMed® II Infusion System.
Primary- To evaluate the effects of the 15 mg E4/3 mg DRSP combination and the 20 mcg EE/3 mg DRSP used as reference combination on ovarian function inhibition at Treatment Cycle 1 and Treatment Cycle 3.Secondary- To evaluate levels of luteinizing…
The objective of the trial is to assess the safety and tolerability of i.c.v. administration of sNN0029 infusion solution at a dose of 4 µg per day delivered via a Medtronic SynchroMed® II Infusion System.
• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…
Part 1To evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple intravenous doses of FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) and FEP-TAZ 3 g (2 g cefepime + 1 g tazobactam) administered every 8 hours (q8h) in healthy adult…
Primary:To evaluate the effects of 15 mg E4/3 mg DRSP, of 30 mcg EE/150 mcg LNG, and of 20 mcg EE/3 mg DRSP on hemostasis, endocrine function and lipid and carbohydrate metabolism parameters during 6 treatment cycles.Secondary:To assess the safety…
- To evaluate the pharmacokinetic (PK) profile of the combination of GLPG3067, GLPG2222, and GLPG2737 following repeated morning versus evening doses given to healthy female subjects - To evaluate the safety and tolerability of the combination of…
Primary objectiveTo evaluate if BRV influences the psychomotor and cognitive impairing effects of ethanolSecondary objectivesTo evaluate the potential PK interactions between BRV and ethanolTo evaluate the safety and tolerability of co-…
Primary Objective(s)The primary objective is to evaluate the efficacy and safety of CNTO 136 administered intravenously in subjects with active, ISN/RPS Class III and IV LN.Secondary ObjectivesThe secondary objectives are:Evaluate the…
The primary objective of the study is to assess the safety and immunogenicity of V212 in a population of adults with autoimmune disease.
The primary objectives of the study are 1) to compare the efficacy of CP-690,550 (5 mg BID and 10 mg BID) versus etanercept (50 mg BIW) for the reduction in severity of plaque psoriasis after 12 weeks of treatment, and 2) to evaluate the safety and…
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• Test the safety of the research drug, telcagepant (MK-0974)• Test the safety of the research study drug telcagepant (MK-0974) in the prevention of menstrually related migraines. • Compare the effectiveness of the research study drug telcagepant (…
The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…
The aim of this Phase II proof of concept study is to assess efficacy, haemodynamics and safety of Terguride vs. placebo in patients with pulmonary arterial hypertension (PAH). Having finished this proof-of-concept study it is intended that patients…
Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.