6 results
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
Objectives: For patients with connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) enrolled in this study, the objectives are as follows:Primary: -To assess the efficacy of bardoxolone methyl relative to placebo.Secondary…
The study will be performed in 3 parts, Parts 1, 2 and 3. In all parts, the purpose is to investigate to what extent APX001 is tolerated. In addition, it will be investigated how quickly and to what extent APX001 is absorbed and eliminated from the…
To provide continuing open-label treatment with bardoxolone methyl as part of this extended access program while collecting ongoing safety and tolerability data of bardoxolone methyl.
* The primary objective of this study is to compare the proportion of warm antibody autoimmune hemolytic anemia (wAIHA) subjects whoachieve a durable hemoglobin response between the fostamatinib and placebo groups.* The secondary objectives of this…
The objective of the clinical study is to evaluate the safety and efficacy of the Adagio Cryoablation System (iCLAS*) in the ablation treatment of persistent atrial fibrillation (PsAF). Data will be used to support a pre-market application (PMA).