3 results
To evaluate the inter- and intra-subject variability in pharmacokinetics (PK) and pharmacodynamics (PD) of study drug following a two-period repeated single dose of 2 mg delivered by subcutaneous (SC) injection in healthy volunteers.
Primary objective: To evaluate the efficacy of IVIg treatment (4 courses of treatment, 3 weeks apart) compared to placebo on pain alleviation. Secondary objectives: 1. Pain intensity, pain qualities, and other SFN related complaints, daily and…
Primary clinical investigation objectives[Safety]The primary safety objective of the clinical investigation is to provide data that demonstrates safety of the device, defined as < 8.3% serious adverse device effects, up to 6 weeks following…