2 results
Approved WMOCompleted
To compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight plus budesonide (9mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. To study safety and…
Approved WMOCompleted
To assess the safety, reactogenicity, and tolerability of increasing GEM intranasal doses (1.25 mg, 2.5 mg and 5.0 mg) and intramuscular doses (0.05, 0.1, 0.2 mg) of the GEM adjuvant, each administration containing as well a standard 2010/2011 Flu…