12 results
Primary objective:Evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of multiple doses of intravenous (IV) ATYR1940 in adults 18 to 65 years of age, inclusive, with FSHDSecondary objective:Explore pharmacodynamic (PD)…
Primary objective: • To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD.Secondary objectives:• To assess the safety and tolerability of 2 different dosing…
Two key questions remain to be answered to further elucidate the mechanism of action: 1) is the effect on glucose metabolism dose dependent in Type 2 diabetes patients? and 2) Does UAG decrease glucose concentrations during an oral glucose loadThis…
From protocol amendment 3 27JUn2022, Clinical Study Protocol Synopsis, page 1Primary Objective• To demonstrate superiority of fianlimab 1600 mg + cemiplimab and/or fianlimab 400 mg+ cemiplimab compared to pembrolizumab, as measured by progression-…
Study A: Validation of productive infection of RSV CHIMStudy B: Effectiveness and immunogenicity of local administration of palivizumab on prevention of experimental RSV infection
It is not known whether recurrent wheeze in preterm children is caused by RSV infection (serial hypothesis) or that RSV infection is the first indication of chronic airway morbidity that would develop anyway (parallel hypothesis). This study aims to…
Primary Objective:- Efficacy of ARGX-113 as assessed by the percentage of "Myasthenia Gravis Activities of Daily Living (MG-ADL) responders" in the acetylcholine receptor (AChR)- antibody (Ab) seropositive population.Secondary Objectives:1…
The objectives of the study are to: -To evaluate the safety and tolerability of MOTREM in patients with septic shock. -To evaluate the effects of MOTREM exposure over up to 5 days in patients with septic shock -To evaluate the PK/PD and dose/PD…
Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To determine main change in ISM-SAF TSS from baseline to C7D1, compared to placebo. Part 3 • To assess the long-term…
Study A: Safety of intranasal administration of palivizumab in healthy adultsStudy B: Effect of local administration of palivizumab on prevention of RSV infection
Study A: Validation of productive infection of RSV CHIM Study B: Effectiveness and immunogenicity of local administration of palivizumab on prevention of experimental RSV infection
Primary:• To compare progression free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the Intent to Treat (ITT) Analysis Set as assessed by investigators according to…