6 results
The primary objective of this study is to assess the comparative safety and efficacy ofAztreonam Lysine for Inhalation (AZLI) and Tobramycin Nebuliser Solution (TNS) in adultand pediatric cystic fibrosis (CF) patients aged 6 years or older with…
To investigate the clinical pharmacokinetics of tobramycin and/or colistin after nasal administration. With this pharmacokinetic parameters the safety of this treatment can be investigated.
Stage 1* To assess the safety and tolerability of single-ascending-dose levels of IW-6463 when administered to healthy subjectsStage 2* To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 when administered to healthy…
Primary-Assess the efficacy of apitegromab compared with placebo using the HFMSE in patients 2 through 12 years oldKey secondary-Assess the efficacy of apitegromab compared with placebo based on the number of patients with clinical improvement in…
Primary* To evaluate the effect of IW-6463 on cerebral blood flow (CBF) in healthy elderly participants* To assess the safety and tolerability of IW-6463 vs placebo when administered to healthy elderly participants for up to 15 daysExploratory* To…
-Evaluate the long-term safety and tolerability of apitegromab in patients with Type 2 and Type 3 SMA-Evaluate the long-term efficacy of apitegromab by assessing changes in motor function outcome measures at prespecified time points-Further evaluate…