4 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…
The primary objective of this study is to evaluate efficacy and safety. Secondary objectives: PK, PK-PD.
PrimaryPart 1: - To determine the respiratory response of low and high doses of GAL-021 in conjunction with a low dose of opioids and hypercapnia in healthy subjects. Part 2: - To determine the respiratory response of low and high doses of GAL-021…
The first main objective is to investigate the pharmacokinetic properties of dry powder amikacin at different dosages and compare the peak serum values to a single i.v. dose. The secondary main objective is to assess the local tolerability of dry…