5 results
The purpose of this first-in-human (FIH) study is to assess the safety, tolerability, pharmacodynamics (PD), and pharmacokinetics (PK) of subcutaneous (SC) VIS171 in healthy participants (single ascending dose [SAD] - Part A) as well as in…
The main purpose of this study is to assess the long-term antibody responses and cellular memory immunity against B. pertussis in a cohort of Dutch children, 8-9 years of age, who have been vaccinated with aP in the first year of life. Furthermore,…
Primary Objectives: To investigate the pharmacokinetic interaction of elexacaftor/tezacaftor/ivacaftor and tacrolimus in adult CF patients using tacrolimus after renal or liver transplantation by:- quantitating the effect of elexacaftor/tezacaftor/…
Primair eindpunt:Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Homozygous or Heterozygous for the F508del Mutation.Secundair eindpunt:Evaluate the long-term efficacy of VX-…
Primary objective (Parts A and B):To evaluate the long-term safety and tolerability of VX-445/TEZ/IVA in subjects with CF who are heterozygous for the F508del mutation and a gating (F/G) or residual function (F/RF) mutation.Secondary objectives (…