6 results
Primary:* Evaluate the safety and tolerability of ALKS 7119 following oral administration of multiple ascending doses of ALKS 7119 in healthy male and female adultsSecondary:* Evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ALKS 7119…
To evaluate the outcome of FISH testing with a set of biomarkers with regard to the prognostic value and the diagnostic accuracy for both sporadic cholangiocarcinoma and PSC related cholangiocarcinoma. Subsequently we want to develop a valid…
In this study we will look at the blood levels of the study compound ziltivekimab. We will investigate how quickly and to what extent different compositions of ziltivekimab are absorbed, transported, and eliminated from the body. Ziltivekimab is not…
The primary objective is to demonstrate the superiority of ziltivekimab 15 mg s.c. once-monthly in reducing the risk of MACE (as defined by the primary endpoint) compared to placebo, both added to standard of care, in participants with established…
To study whether ziltivekimab therapy reduces arterial wall inflammation as assessed by imaging, and reduces the systemic inflammatory tone as assessed by circulating monocytes, inflammatory biomarkers and proteomics.
To evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ALKS 7119 following oral administration of single ascending doses of ALKS 7119 in healthy male adults